Literature on pain protocols
In this before and after implementation study in a UK Emergency Department, the authors retrospectively evaluated the effect of an analgesic protocol. In this protocol, treating physicians should administer oral analgesia or IV morphine to patients with fracture pain, depending on injury severity and fracture type.
The analgesic protocol was presented at a staff meeting at the same time as the baseline results of the primary audit were presented as well.
In this protocol pain scores were not mentioned and analgesic choices were made depending on the type of fracture. By the way, interesting to read that patients with significant head injury were supposed to be given IM diclofenac (!) (or IV morphine).
Although significantly more patients received analgesia after implementation, it should be noted that - as in many other pain studies - pain treatment was the worst before implementation, but was still bad after implementation of the protocol.
In patients with minor fractures, nearly 70% still got no pain medication offered and in admitted patients this number was 22%.
However, to end with a positive note, the IV route of administration was recognized as a superior route and was used in nearly 40% after implementation.
It is certainly nice to read that - already back then in 1996 - nerve blocks were explicitly mentioned in the pain protocol and this local anesthetic technique was mentioned before the administration of systemic opioids!
The authors included all consecutive patients during 2 periods (before and after implementation).
It was a retrospective study, therefore prone to potential (unknown) confounding factors, for which no correction methods were applied. It appeared as if patients were interviewed in a later stage and recall bias might have influenced results. Methodology and data collection were not clearly described. No formal sample size calculation was performed.
It was not clear whether the protocol was intended for use by physicians only, but it probably was. Post-implementation data were collected in the month following implementation, therefore could have been falsely positive due to a 'honeymoon' period.
Implementation of a pain protocol, not based on pain assessment, but on injury type increased the use of IV pain medication in adult patients with fractures who are discharged from the Emergency Department as well as patients who were admitted to the hospital.
Level of evidence 4
In this retrospective case-series, the authors evaluated the safety profile of a previously implemented pain protocol in which nursing staff could administer and subsequently titrate IV pethidine or IV morphine to adult patients after signing off by the treating physician. This means this was a nurse-driven pain protocol (not nurse-initiated). The exact protocol was not reported in the publication.
Although the authors stated that the use of titrated IV pethidine and IV morphine was safe to use in a nursing-managed pain protocol, there was an incidence of 4.7% of adverse events. Although no respiratory depression was noted, there were 17 patients with hypotension; 1 patient with an allergic reaction and 1 patient with a vasovagal reaction. Of the patients who developed hypotension, 6 patients had sepsis, cardiogenic shock, bradycardia or they used vasodilatory drugs and subsequently developed hypotension.
Overall, pethidine was used most often (74%) followed by morphine (25%) and both were used in 1% of patients.
This was the first study to evaluate the safety of an Emergency Department based nurse-driven pain protocol.
The authors included all consecutive patients in order to minimize selection bias or differential loss to follow-up.
This study had a retrospective design, with high risk of confounding.
The primary outcome was the occurrence of adverse events and these might not have been documented in all patients properly (information bias). The study population consisted of one patient group without a comparison group. Lastly, it is not exactly clear how long after implementation of the pain protocol this study was performed. No formal sample size calculation was performed.
The use of a nurse-driven pain protocol in adult patients with various traumatic and non-traumatic causes of pain in the Emergency Department is safe in general, however when using IV pethidine and IV morphine, patient selection should be careful in order to prevent adverse events, such as hypotension.
Level of evidence 4
The same researchers that performed the safety profile study of a nurse-driven IV narcotic pain protocol published this comparative, retrospective observational study in which they evaluated the effect of the implementation of the nurse-driven pain protocol. In this protocol nurses were able to titrate opioids after initial signing off by the treating physician.
In the current study the main focus was on the route of analgesic administration (IM versus IV) in Emergency Department patients presenting with renal colic. Patients treated according to the protocol were compared with patients 1 years before implementation.
The authors emphasized the importance of IV analgesic administration, as titration is possible and this has faster onset. In order to prevent the ‘honeymoon’ period, data of the second patient group were selected at 2 years after implementation.
Because of the retrospective design, confounders may have influenced study results. As the second study period was 2 years after implementation, other factors might have influenced study results.
Selection bias cannot be excluded to have played a role, as well as information bias as data were collected by chart reviews of a single reviewer who was trained, however it was not described what level of training this was.
The pain protocol that was implemented included incorporation of pain measurement as routine observations, but these results were not presented.
The implementation of a nurse-driven, titrated IV narcotic pain protocol increases the proportion of IV administration at the expense of IM administration in adult patients presenting to the emergency department with renal colic.
Level of evidence 4
The same Australian research group that published the 2 previous studies described above, performed the current study in which a nurse-driven IV titrated narcotic pain protocol was evaluated. In the current study they evaluated the effect in patients with pain due to long bone fractures and the authors found that (as well as in renal colic patients in the former study) IV administration of narcotics improved significantly and the IM route of administration decreased significantly after implementation of the protocol as compared to the baseline situation.
The authors also described the results of a reviewing process that preceded to the development of the nursing protocol, in order to identify major deficiencies in pain management. These results were:
- Pain was poorly recognized and documented
- Inadequate dosages of pain medication were administered
- Routes of administration of analgesics were inappropriate
- There were delays in analgesic administrations
- Pain management was not regarded high priority
The proposed strategies that eventually led to the development of the nurse-driven pain protocol were: routine patient reporting of pain; trying to change the Emergency Department culture surrounding pain and pain management and propagating the use of IV opioids as the preferred method of administration of narcotic analgesia.
This was a retrospective study and confounding probably influenced results and as the second study period was 2 years after implementation, other factors might have influenced study results as well.
A single reviewer (with unknown level of training and experience) collected data utilizing chart review and selection bias and information bias could have influenced results.
The pain protocol that was implemented included incorporation of pain measurement as routine observations, but these results were not presented.
The authors state that analgesic timelines were not evaluated and that it was questionable whether these study results could be extrapolated to other conditions (questionable external validity).
The use of a nurse-driven IV titrated narcotic pain protocol increases the use of IV narcotic analgesic administration compared to IM administration and therefore improves pain management in patients with acute long bone fractures.
Level of evidence 4
This was a prospective observational case-series in which the authors evaluated the effect of a nurse-initiated pain protocol in which nursing staff could administer opioids autonomously. The protocol allowed triage nurses to initiate and titrate IV morphine in patients with pain due to various causes: 2.5mg IV morphine every 5 minutes until the patient was comfortable or up to a maximum of 0.1mg/kg.
Nursing staff had to have at least 18 months emergency nursing experience, had completed 3 day course in triage and a detailed education session. There were strict protocol exclusion criteria documented, when nursing staff wanted to initiate analgesia:
- VAS < 5
- patients were not allowed to be younger than 18 and older than 75 years
- hemodynamic instability (heart rate >110/min; systolic blood pressure <100mmHg
- altered level of consciousness (EMV <15)
- respiratory rate <12/min
- oxygen saturation <95% on room air
- possible ischemic chest pain
- dyspnea as major presenting complaint
- presenting with headache
- allergy to morphine
This was a prospective study and therefore, data was collected for study purposes directly, which decreases information bias and increases data value.
Moreover, this was the first prospective (observational) study in which the effect of a nurse-managed pain protocol in the Emergency Department was evaluated and the first study to investigate the effects of an IV narcotic nurse-initiated pain protocol.
This was a single-group study without a comparison group, therefore the exact effect of implementation of the pain protocol cannot be determined. Patients were recruited at the moment the triage nurse would use the pain protocol and the study population consisted of a convenience sample with potential selection bias, as patient selection could have been influenced by factors such as overall activity in the department; crowding; work load; level of current staffing; opportunities to acquire morphine and to record data at that specific moments, etcetera.
The authors concluded that patients received analgesia 26 minutes earlier (as time to be seen by a physician was 26 minutes after administration of analgesics in triage). However, it is not unimaginable that a treating physician went to treat other patients first, because pain of study patients was already being treated adequately by protocol. Especially in patients with previous kidney stones and presenting as a classic renal colic, treating physicians might have waited for lab results and urinalysis before seeing the patient. Therefore the time gain of 26 minutes is too easily concluded.
The authors mention 15 potential serious adverse events (4.3%), however they sum up 25 (7.2%).
The use of an IV narcotic titrated nurse-initiated pain protocol in triage can assure timely administration of adequate pain treatment and adequate pain relief in patients presenting to the Emergency Department with various painful conditions, however, the use of morphine leads to several adverse events.
Level of evidence 4
This was a retrospective observational cohort study in which the authors evaluated the time to analgesic administration in patients receiving pain medication according to a nurse-initiated IV opioid pain treatment protocol compared to physician-directed analgesic administration.
In previous studies the same research group evaluated a nurse-driven narcotic pain protocol and its effect on several factors. In the current study they evaluated the effect of a novel, nurse-initiated opioid analgesia protocol that was implemented shortly before data collection. This protocol allowed nursing staff (who were specially trained and accredited for this purpose) to initiate and manage titrated IV opioid analgesics for selected patients presenting with certain painful conditions, before physician's assessment.
Data was collected by 2 reviewers and the authors did their best to minimize selection bias, information bias and differential loss to follow-up by collecting data from several source documents, such as Emergency Department patient records; drug charts; nursing observation charts and a narcotic drugs register, which they used to cross-check if analgesia was nurse-initiated. A sample size calculation was performed in order to detect a reduction in time to analgesia from 45 to 30 minutes.
Unfortunately, the planned sample size of 224 patients was not reached, because their hospital suspended the nurse-initiated narcotic pain protocol as its legality was challenged by an external governmental institution.
It was unclear whether the reviewers were blinded for the results of each other / collected data independently. No referee was appointed in case of disagreement and note interpretation could have influenced results, leading to information bias.
It was a retrospective study with high risk of potential (unknown) confounders.
The nursing-initiated analgesia group had higher triage acuity category scores, possibly reflecting higher pain scores, which might have influenced results (pain scores were not recorded in the study).
Finally, the authors mention in the results section that no cases of respiratory depression occurred, however, occurrence of adverse events was not mentioned in the methods section and therefore it is not known whether it was specifically and systematically looked for by the data reviewers.
The implementation of an IV narcotic nurse-initiated pain protocol probably shortens time to adequate analgesia in adult patients presenting to the Emergency Department with biliary and renal colic.
Level of evidence 4
The authors of this comparative, before and after implementation study in the USA evaluated the effect of implementing a pain management protocol in patients who had established trauma activation criteria.
The protocol was nurse-driven (physician order was necessary initially, but further assessment and administration of analgesics was on discretion of nursing staff) and consisted of the administration of IV fentanyl 25-50ug and titrated each 5 minutes (stable patients) and each 15 minutes (potentially unstable patients). For this purpose, patients evaluated at the trauma bay were classified as unstable; stable but with abnormal viral signs and stable vital signs. Before implementation, the protocol was officially presented to staff.
The authors found that time to analgesia significantly decreased and that there were no adverse events contributable to IV fentanyl administration.
A sample size calculation was performed in order to detect a 50% reduction in time to analgesia (assuming before mean time of 72 minutes)
It was not clear whether the after-implementation group was recruited prospectively and by whom. The before-implementation group consisted of a historical control group.
After implementation 104 patients were recruited and 74 were deemed appropriate to receive protocolized fentanyl, of whom 67 actually did. The difference of 30 patients (104 to 74) were patients in the unstable vital signs group who actually received IV fentanyl. However, these patients were not included in the analyses and it is not clear why not. Moreover, 18 additional patients from the same group who got analgesics were included in the study.
The amount of 25-50ug IV fentanyl might be too low for some patients, as dosages were not calculated by body weight.
Prehospitally administered analgesia was not accounted for.
The use of a nurse-driven pain protocol in trauma patients evaluated in the trauma bay utilizing IV fentanyl in incremental dosages reduces time to analgesia and seems safe to use.
Level of evidence 4
This was a prospective, observational study in which the authors evaluated the use of a triage pain protocol in a Hong Kong Emergency Department.
According to the protocol, nursing staff was allowed to administer acetaminophen 1000mg orally to patients with minor musculoskeletal injuries. Moreover, pain assessment was added to standard care using 100mm VAS pain scores and triage nurses received a 2 hour training about pain management concepts, the pain protocol and study logistics.
Study results showed a significant increase in pain assessment after implementation, however there was a remarkable lack of protocol adherence regarding administration of acetaminophen. Of patients included after implementation, only 22% of patients who would have liked to receive acetaminophen actually received this.
The authors also performed a qualitative study in order to find out beliefs and thoughts of both patients and nursing staff regarding nurse-initiated triage analgesia and desire for pain medicaiton.
Patient beliefs included fear of adverse events of analgesics; analgesics should only be used in severe pain and the belief that pain should be beared as much as possible.
Nurses mainly thought that there was no time when the waiting room was full and they needed to get used to working with the new protocol.
Not all consecutive patients were recruited as patients were only approached for inclusion in the study during office hours. This could have led to selection bias.
When present, a research assistant (not involved in care), approached patients for inclusion. Treating nursing staff could have been influenced by their presence and therefore (unconsciously) changed their behavior, potentially resulting in a Hawthorne effect, (although study results certainly do not point in that direction).
There was a large difference in waiting time before a patient was evaluated by a physician, in favor of the phase before implementation of the pain protocol. The authors explain this because of 'differences in medical staff skill mix' between the 2 periods (more senior staff available in first period). These differences might have influenced other study results as well. Other unknown confounding factors might have been present.
The groups were divided in pre- and post-implementation groups as was to be expected. Additionally, the post-test group (after implementation of the pain protocol) was sub-divided in patients who actually received acetaminophen and patients who did not receive this. This resulted in small study groups. Conclusions drawn from these groups should be approached with caution as the study was probably not powered to detect any meaningful differences. Finally, no sample size calculation was performed.
The implementation of a triage pain protocol in which nursing staff can administer oral acetaminophen to adult patients with minor musculoskeletal injuries leads to increased pain assessment. This study failed to show increase in analgesic administration or superior pain treatment. It is worthwhile to evaluate thoughts and beliefs of both patients and health care staff when optimizing pain management in the Emergency Department.
Level of evidence 4
In this Emergency Department observational cohort study, the investigators evaluated the use of a triage pain protocol. Analgesic choices depended on VAS pain scores and consisted of orally administered or IV administered pain medication.
This meant that patients with a VAS pain score somewhere between 1mm and 33mm (mild pain) could receive ibuprofen 600mg orally.
In case the VAS pain score was between 34mm and 66mm (moderate pain), the triage nurse was allowed to administer ibuprofen 600mg AND hydrocodone 10mg orally, in combination with acetaminophen 1000mg orally.
In case of severe pain (VAS pain score between 67mm and 100mm), the triage nurse had 2 options: the analgesics as described above in case of moderate pain OR 5mg IV morphine. The latter was recommended in case of high suspicion of a fracture or in case of failure of oral opioids prior to arrival in the Emergency Department.
Nurses were educated in a 15-minute session by the study PI at trial start. Moreover, nursing quality assurance audits were performed monthly, including feedback given to nursing staff as a whole and individually regarding enrollment of eligible patients.
They used research associates who were blinded for the study purpose.
It can be assumed that patients were recruited prospectively, however this was not explicitly described.
Patients were not recruited consecutively and selection bias potentially influenced the study results.
is a significant threat to the internal validity of this study. Performing the study itself might have led to an increased awareness of pain treatment and therefore a Hawthorne effect.
However, an historical patient group was used as comparison and retrospective data is prone to potential confounding factors, for which no corrective measures were described.
When compared to a historical control group, a triage pain protocol did not improve pain relief at discharge, but it did improve analgesic administration.
Level of evidence 4
Decosterd I, Hugli O, Tamchès E, Blanc C, Mouhsine E, Givel JC, Yersin B, Buclin T
Oligoanalgesia in the emergency department: short-term beneficial effects of an education program on acute pain
The authors of this Swiss prospective pre- and postimplementation cohort study evaluated the effect of implementing a structured, VAS-based pain protocol.
The pain protocol included:
VAS <4: APAP and/or NSAID (ibuprofen 600mg or diclofenac 75mg
VAS >4: morphine 0.1mg/kg IV (titrated to max 0.15mg/kg) AND APAP or NSAID
No opioid administration in headache patients.
Although the pain protocol analgesics were to be prescribed by the physician, the protocol stated explicitly that this was a joint-responsibility of both physicians and nurses, as was the goal to administer analgesia within 15 minutes and to perform reassessments every 15 minutes.
Implementation was combined with educational sessions that covered evaluation and treatment of acute pain. Pain guidelines were widely distributed (in pocket-form and as posters) among physicians and nurses and discussed during all formal staff meetings, rounds and shift-changes. Additionally, there was a hotline installed that was staffed by an experienced ED physician (for urgent questions during office hours).
As a result, they found that pain assessments increased, as did reassessment and reporting of pain severity, however still half of patients did not have their pain severity documented after implementation (26% by physicians and 45% in nurses).
Administration of pain meds increased to 63%, as well did the administration of IV morphine in higher dosages (mean dose from 2.4 to 4.6mg). This all resulted in more effective pain management as VAS pain scores decreased significantly more after implementation.
This was a prospective cohort study.
Patients were recruited by a dedicated research assistant, therefore confounding such as crowding and staff-related factors were minimized.
A patient flow chart was included reporting excluded patients including reasons of exclusion.
Patients were not recruited consecutively (however, bias was minimized by recruiting during different 8-hour shifts so that admissions during 24 hours were represented in the data as much as possible).
No sample size calculation was performed.
Due to the prospective, unblinded and observational design, the Hawthorne effect could not have been excluded as a confounder.
Implementation of a clinical pain management guideline improved pain assessments and reassessments, as well as analgesic administration and efficacy and patient satisfaction in patients presenting with pain of any cause.
Level of evidence 2b
The authors of this Israelian study prospectively evaluated implementation of a structured pain protocol combined with an educational intervention in patients with minor-to-moderate traumatic injuries and patients with renal colic.
Before implementation available analgesics were APAP, dipyrone, acetylsalicylic acid, ibuprofen, naproxen, buprenorphine, parenteral diclofenac, meperidine, morphine and fentanyl. The structured pain protocol consisted of:
VAS 1-3: dipyrone, aspirine, APAP, ibuprofen or naproxen
VAS 4-6: APAP with codeine, buprenorphine or dypirone with ibuprofen
VAS 7-10: IV morphine, fentanyl, ketamine or nerve blocks
Educational sessions were 2-hours didactic small-group lectures and a 1-hour case-based discussion involving physicians and nurses. Moreover, during the 3-months after educational sessions, patient charts spot-checks were performed and personal feedback to treating staff provided.
The study had a single-blinded design as Emergency Physicians and nurses were unaware of the purpose of the study.
Data was collected by a dedicated physician, not involved in care for recruited patients.
Both pre- and after-intervention data were collected prospectively
Patients were only included in case the research physician was present (non-consecutively).
No sample size calculation was performed beforehand.
Although the administration of analgesia improved impressively, it is remarkable that there was no difference in pain scores (analgesic efficacy). This might have been caused by an unknown confounder or factor that had influenced patient selection.
The implementation of a VAS-based pain protocol in combination with educational sessions for physicians and nurses including personal feedback improved analgesic administration and time to analgesia in patients with minor/moderate traumatic injuries or renal colic significantly.
Level of evidence 2b
Gawthorne J, Welch S, Robertson F, McDonell K, Finckh A
Implementation of a guideline to improve prescription of analgesia for adult trauma patients in an emergency department
The authors of this retrospective observational cohort study in Australia evaluated the effect of implementation of a pain management guideline in trauma patients (intubated and non-intubated), identified from a trauma database.
The pain management guideline consisted of recommendations for intubated as well as for non-intubated patients.
Intubated patients: morphine and midazolam infusions (unless neurological injury or age >70 years, then morphine and propofol was used).
Non-intubated patients: NRS-based;
NRS 5 or lower: acetaminophen/codeine PO AND ibuprofen or indomethacine PO (in case no contraindications for NSAIDs. Reassessment at 30-60 minutes NRS >5: oxycodone 5 or 10mg
NRS >5: IV morphine 2.5mg titrated up to 0.1mg/kg AND acetaminophen 1000mg PO. NSAID added in case no contraindications. If longer opioid pain treatment anticipated, initially subcutaneously morphine was utilized and after 24 hours PCA was considered.
After development of this guideline, educational sessions were held in 2 separate months for both medical and nursing staff, including simulation training and feedback from audit data. Additionally, large posters of the guideline were displayed in resuscitation bays and throughout the ED and were made available electronically. PCA accreditation was required for nursing staff.
The authors reported increased analgesic administration in both intubated (32 to 68%) as well as non-intubated patients (86 to 100%). Median time to analgesia in non-intubated patients decreased from 38 to 14 minutes. Documentation of pain scores increased non-significantly.
The pain management guideline was specifically developed for major trauma patients (in whom pain management usually is neglected due to other high treatment priorities), including intubated patients.
Along with implementing the guideline, extensive educational sessions were held during 2 separate periods with audit feedback and simulation training.
Retrospective chart review and therefore, unknown confounders might have influenced study results.
No formal sample size calculation was performed.
It is not clear who selected the patients.
The control group was selected during a period of 5-6 months and the post-implementation group during a period of 2-3 months.
It was not explicitly described how long after implementation of the guideline, the post-intervention cohort was included in the study.
Implementation of a clinical pain management guideline in combination with extensive educational sessions for Emergency Department treating staff increased analgesic administration in intubated and non-intubated major trauma patients and pain assessment (in the latter). Time to analgesia decreased significantly.
Level of evidence 4
Muntlin Å, Carlsson M, Säffenberg U, Gunningberg L
Outcomes of a nurse-initiated analgesic protocol for abdominal pain in an emergency department: a quasi-experimental study
In this Swedish prospective study the authors examined the effect of an intervention that consisted of two parts:
1. Education session for nursing staff about abdominal pain; pain measurement and analgesics
2. Protocolized pain assessment by nursing staff as well as nurse-initiated IV opioid pain treatment.
In case patients had non-traumatic abdominal pain with an NRS pain score between 4 and 8, 2mg IV morphine could be administered with additional 1mg incremental IV dosages every 3 minutes up to a maximum dose of 10mg.
Exclusion criteria of this protocol were: hemodynamic or respiratory instability; pain intensity > 8; allergy to morphine or pregnancy.
Besides implementation there was awareness regarding the value of educational sessions and protocolized pain assessment. Consecutive patients were included with well-defined criteria.
Patients were questioned regarding their experience with pain management in the Emergency Department.
The study design was quasi-experimental, utilizing a so-called A1BA2-design, in which A1 represented baseline; B implementation and A2 return to baseline (during which the implemented pain protocol was retracted again).
During the study course, there was significant change in staff (continuous consultants present during office hours). These changed could have confounded study results, however this was recognized and might have been corrected by utilizing study phase A2.
Although the implementation of the pain protocol resulted in improved pain assessment and pain score documentation (96%!), pain scores at discharge were not recorded systematically. Therefore, only the least pain that was experienced during the stay in the Emergency Department could be compared between the groups. No formal sample size calculation was performed.
The questionnaire that was utilized was designed for post-operative pain originally. Therefore, it was not validated for use in the Emergency Department to evaluate patients with acute pain.
Implementation of an IV opioid nurse-initiated pain protocol based on morphine, combined with an extensive educational session, resulted in increased pain assessment; increased analgesic administration and decreased time to analgesia in adult patients presenting to the Emergency Department with non-traumatic abdominal pain.
Level of evidence 2b
Steinberg PL, Nangia AK, Curtis K
A standardized pain management protocol improves timeliness of analgesia among emergency department patients with renal colic
The authors of this before and after observational cohort study compared effectiveness of a NSAID/opioid pain protocol in patients with renal colic in an Emergency Department in the USA.
The protocol prescribed ketorolac 30mg IV AND morphine 0.05-0.1mg/kg IV (and allowed for a 2nd dose of morphine if pain persisted). It was not explicitly described whether nurses were allowed to administer these drugs autonomously, therefore, it was probably physician-driven analgesia.
Physicians and nurses were educated about the study and its background before implementation of the pain protocol.
The authors found that implementation of this pain protocol resulted in a 35-minute decrease in time to effective analgesia.
A power calculation was performed in order to detect a time reduction of 50% (time to analgesia)
Patient flow chart was shown, including reasons why patients were excluded.
The control group was a historical cohort and data were collected retrospectively and therefore prone to confounding factors.
The calculated sample was 45 patients in each group, however, in the after-implementation group 44 patients were analysed. Moreover, 1 patient was excluded from the prospective group as time to analgesia was 446 minutes and this patient was considered a statistical outlier. The analysis including this patient was not reported.
The patient flow chart only shows the prospective arm, it is not known what patients were excluded in the historical cohort group, therefore selection bias might have occurred. However, in order to minimize this, a table 1 was reported (baseline parameters) showing no differences between the groups.
In the prospective after-implementation group, a Hawthorne effect might have influenced study results.
Implementation of a pain protocol utilizing NSAIDs and opioids decreases time to effective analgesia in patients with renal colic.
Level of evidence 4
Finn JC, Rae A, Gibson N, Swift R, Watters T, Jacobs IG
Reducing time to analgesia in the emergency department using a nurse-initiated pain protocol: a before-and-after study
The authors of this Australian before- and after observational cohort study evaluated the use of a nurse-initiated pain management protocol. The protocol was NRS-based;
NRS 1-3: APAP 1000mg orally (1500mg in case weight > 100kg) OR ibuprofen 400mg
NRS 4-6: APAP/codeine 1000/60mg orally OR ibuprofen/codeine 600/38,4mg
NRS 7-10: APAP 1000mg AND ibuprofen 600mg orally AND IV morphine 2.5mg bolus titrated up to 10mg OR endone 5-10mg orally.
Additionally, information sessions were held for nursing staff and specific training and demonstrated competence was required for nurses to administer analgesics autonomously. Hard copies of the protocol were displayed.
This resulted in decreased time to initial pain score as well as analgesic administration. In patients with severe pain, 3-points reduction in NRS pain scores occurred more often and adequacy of analgesic effect was significantly improved after implementation, however numbers of these subgroups were small.
Formal sample size calculation was performed.
Patients in the intervention group were recruited by research nurses, not involved in direct clinical care.
The control group was a historical control group, not-consecutively recruited and therefore prone to potential (unknown) confounders and bias. There were several significant baseline differences between the control group and the intervention group.
Moreover, patients in the intervention group were also not included consecutively, as research nurses were not present 24 hours and 7 days per week.
Although the pain protocol was ‘nurse-initiated’, opioid analgesics still had to be signed off and therefore, administration of these was not nurse-initiated.
The group of patients with a second pain score recorded was very small (especially in the pre-intervention group), therefore the study was probably not powered to detect meaningful differences regarding the outcomes ‘effective pain management’ (3-point NRS decrease in severe pain) and ‘adequacy of analgesic effect’.
The authors mention that medication dosage was not reliably entered into the study database and therefore protocol adherence cannot be ascertained. This might have confounded results, especially as departmental issues, such as crowding were not accounted for as well.
Implementation of a nurse-initiated protocol in which nursing staff was allowed to administer non-opioids autonomously resulted in decreased times to initial pain score and initial analgesia.
Level of evidence 4
The authors of this retrospective case-series reported the effect of a high-dose opioid pain treatment protocol in adult patients presenting with vaso-occlusive crisis in sickle cell disease in an Emergency Department in the United States.
The protocol was partly nurse-initiated (first dose autonomously administered and 2nd and 3rd dose after consulting physician) and consisted of:
- in case patient already took opioids last 24 hours: IV/SC hydromorphone 2mg OR morphine sulfate 10mg IV/SC and titrated after 20 minutes with 4 and 20mg, respectively. The initial dose was combined with ibuprofen 600mg PO + diphenhydramine 25mg PO (in case of itching).
- in case patient did not take opioids last 24 hours: opioid dosages less than described above.
All physicians and nurses were educated in using the protocol, including education regarding a sedation scale that was used in reassessments.
They found that although high doses were administered (mean IVMSE was 63 during Emergency Department stay, adverse events occurred in 63/603 patient visits. These were respiratory events, not requiring interventions.
The inter-rater reliability of IV morphine sulfate equivalents that were calculated in this study was tested with a blinded second research assistant (Pearson r 0.84)
Multiple logistic regression was used in order to identify factors that might predict abnormal vital signs.
This was a case-series without a control group.
Regarding retrospective analysis of adverse events, it must be noted that patients with vaso-occlusive crises in sickle cell disease usually receive additional oxygen (by nasal canula). It was not possible to make a distinction between standardized oxygen administration or as a response to hypoxemia/hypoventilation. This might have confounded the rate of adverse events.
Nurse-managed opioid pain treatment utilizing high IV dosages in patients with vaso-occlusive crises in sickle cell disease is safe.
Level of evidence 4
The authors of this USA study evaluated the effect of implementation of a so-called ‘Pain Management 30 Policy’, that emphasized administering analgesics as soon as possible (30 minutes target from triage) to patients presenting with severe pain, instead of awaiting complete patient evaluation and diagnostics. The pain protocol was physician-driven.
No specific analgesics were included in this policy and acetaminophen (IV and PO), ketorolac parenteral and opiates were utilized most frequently.
Paradoxically, the authors found that after implementation of this 30 minutes analgesia target, median time to analgesia increased and proportionally less patients with severe pain received pain meds within 30 minutes. As a possible explanation, increased patient volume from 973 to 1058 patients per week (8.7% increase) was reported, as the authors found increased time to allocate patients to a bed from triage.
By starting recruitment 5 months after implementation, the authors aimed to minimize bias by the Hawthorne effect (although, by the retrospective design of this study this would probably have been of little significance) and, additionally, the honeymoon-effect.
A sample size calculation was performed in order to detect a 20% improvement in proportion of patients who received analgesics within the 30 minutes target time.
The authors evaluated all eligible patients and explicitly reported the patients who were excluded from the study, minimizing selection bias.
This was a retrospective study and was vulnerable to potential confounding factors, such as Emergency Department crowding and other department- or staff-related factors. Moreover, information bias might have influenced results.
Baseline groups were not identical in sex, as significantly more female patients were represented before implementation, this might have influenced the study results.
Implementing a pain management policy that required analgesic administration within 30 minutes in patients with severe pain with selected (presumed) painful conditions paradoxically resulted in delayed time to analgesia as compared to a historical control group. Emergency Department crowding might have played a role.
Level of evidence 4
The authors of this retrospective before- and after implementation study from the USA evaluated the introduction of a triage pain protocol that was built in the electronic medical record system.
The protocol was meant for adult patients between 18 and 65 years of age presenting to the Emergency Department with 1 of 6 selected conditions / complaints: back pain; dental pain; extremity trauma; sore throat; ear pain; pain due to an abscess.
The triage nurse was allowed to administer acetaminophen, ibuprofen or oxycodone autonomously and was able to give additional medication one hour later in case NRS pain scores remained > 5.
A large group of patients was screened for eligibility in this study.
Although a respectively small number of patients received analgesics according to protocol, it seems positive that a total of 489 patients received protocolized pain medication of conditions not described in the protocol. This means nursing staff probably feels comfortable utilizing this pain protocol.
The study was retrospective and therefore potential (unknown) confounding factors might have played a role. It was not clearly described who collected the data and what experience of training this / these person(s) had.
A total of 1002 patients received pain medication according to the protocol, this seems a small number compared to the total study population. Reasons for lack of adherence with the protocol were not described in the study. The authors mention as limitation that study results might have been influenced by variation in Emergency Department patient volumes and crowding.
Pain scores were not recorded and might have influenced study results.
Implementation of a nurse-initiated triage pain protocol in patients' electronic medical records resulted in significant shorter times to orally administered analgesia in patients with several minor painful conditions.
Level of evidence 4
Van Woerden G, Van den Brand CL, Den Hartog CF, Idenburg FJ, Grootendorst DC, Van der Linden MC
Increased analgesia administration in emergency medicine after implementation of revised guidelines
The authors of this Dutch prospective observational cohort study evaluated the effect of implementing a nurse-initiated pain protocol in adults presenting with pain of various causes. These causes were not reported, as patients were subdivided into specialties who treated them and not the conditions they presented with.
The pain protocol included the following:
NRS 4-6: acetaminophen orally, and when necessary in combination with NSAIDs and/or tramadol orally administered
NRS 7-10: piritramid IV (in combination with acetaminophen)
Nursing staff was educated face-to-face and pocket-size versions of the protocol were distributed and posters were placed in the Emergency Department.
They found that the rate of analgesic administration increased significantly, but still was very low after implementation: 31.7%. NRS at moment of discharge from the Emergency Department was missing in 46% of patients in total.
It was a comparative study.
The authors analyzed several previously published confounding factors that might influence analgesic administration by performing both univariable and multivariable logistic regression.
The authors recognized some limitations and tried to correct these, such as the administration of prehospital analgesics that was unequally divided over the study groups.
It was not described who performed the data collection
No sample size calculation was performed
The authors reported that it was not clear whether analgesics were administered by nurses utilizing the protocol or by treating physicians. There are 2 important things to mention about this limitation. Firstly, the authors describe the study being a prospective study, however the distinction between protocolized pain treatment or physician-driven pain treatment should have been easily made then (moreover, it was described that data collection was conducted from the medical records). Secondly, if this distinction cannot be made, we cannot conclude whether the increase in analgesic administration is because of nurse-initiated analgesia or just because of increased pain awareness among all health care staff.
After implementation of a nurse-initiated pain protocol utilizing oral analgesics and IV piritramid in severe pain, the analgesic administration increased, but still was suboptimal.
Level of evidence 4
Pierik JGJ, Berben SA, IJzerman MJ, Gaakeer MI, Van Eenennaam FL, Van Vugt AB, Doggen CJM
A nurse-initiated pain protocol in the ED improves pain treatment in patients with acute musculoskeletal pain
The authors of this prospective, observational, before- and after-implementation study from The Netherlands evaluated the effect of implementing a nurse-initiated pain protocol in patients with acute musculoskeletal injuries. The pain protocol was based on a Dutch national pain treatment guideline, the major change was structural pain measurement. Moreover, nurses were allowed to administer analgesics, including opioids without assessment autonomously. The protocol was NRS based and consisted of acetaminophen as first choice in mild and in moderate pain (oral or IV). NSAIDs or tramadol could be administered as well.
In severe pain, IV morphine 0.1mg/kg or fentanyl 1-2ug/kg can be administered OR IV esketamine 0.25mg/kg.
The authors found a significant increase in analgesic administration. The proportion of patients to whom pain medication was offered increased significantly from 46.8% to 68%, however 21.9% of patients refused analgesics. Median NRS scores decreased significantly from 1.46 to 2.02 NRS points. This difference was not significant when defined as a 33% proportional decrease patients who actually received pain medication.
There were no differences in length of stay or patient satisfaction.
This was a prospective study in which patients were included consecutively and a formal sample size calculation was performed. Prehospital analgesics were accounted for.
The first study to evaluate a nurse-initiated protocol in which esketamine was allowed (although not reported how often this was administered after implementation).
Besides absolute decreases in pain scores, relative decreases in percentages were reported as well.
Important to mention that at discharge 69.2% still had moderate to severe pain (before this was 77%).
Standardized assessment of NRS pain scores were part of the protocol, however, patients who did not provide pain scores were excluded from the study. It is unclear how many patients were excluded for this reason and whether they were always asked for pain scores, as this might have confounded results. Moreover, treating nurses recruited the patients and this could have influenced selection. Therefore, confounding factors such as crowding or other departmental or staff-related issues might have played a role.
Relatively large proportion of patients had fractures (up to 70%), more than other comparable studies (in which strains and sprains are the largest group of patients with acute musculoskeletal injuries). Therefore, it is unclear whether the study results are representative for all Emergency Departments.
The tool with which patient satisfaction was measured, was not explicitly reported. It could have been that satisfaction with Emergency Department treatment in general was measured. There was no significant difference.
Implementation of a nurse-initiated pain protocol including IV opioids and IV esketamine in severe pain arising from acute musculoskeletal injuries results in more adequate and faster pain relief.
Level of evidence 2b
Ridderikhof ML, Schyns F, Schep NW, Lirk P, Hollmann MW, Goslings JC
Emergency Department pain management in adult patients with traumatic injuries before and after implementation of a nurse-initiated pain treatment protocol utilizing fentanyl for severe pain
The authors of this Dutch retrospective observational study evaluated the effect of the implementation of a nurse-initiated pain treatment protocol. According to the protocol, nursing staff was allowed to administer analgesics, including opioids, fully autonomously and based on NRS pain scores.
In case pain was minor (NRS 1-3): oral or IV acetaminophen 1000mg was offered.
When pain was moderate (NRS 4-6): oral diclofenac or tramadol was offered (besides acetaminophen).
In case of severe pain (NRS 7-10), IV fentanyl was administered (besides acetaminophen), initially 1ug/kg (0.5ug/kg, when age >60 years) and subsequent dosages of 0.5ug/kg could be given as well in case pain persisted. The goal was to reach an NRS pain score < 4. Before nursing staff could use the pain protocol, they had to attend a 1 hour educational session, which was signed off.
This was the first nurse-managed pain protocol study in which IV fentanyl was evaluated.
The authors tried to minimize selection bias and information bias by utilizing 2 independent reviewers (of whom 1 was blinded to study purpose) and previously proposed chart review criteria.
Not a single adverse event was recorded, however, as this was a retrospective study, it was prone to information bias, specifically regarding adverse events. Moreover, the study was probably not powered to detect fentanyl-related adverse events.
The authors state that frequent audits feedback to staff increased the late implementation results at 18 months, however this was not causally determined and other confounders probably influenced results as this follow-up period was rather long.
Analgesia that was already taken prehospitally was not accounted for. Even after implementation, pain treatment and assessment was suboptimal and the majority still got no pain medication nor had their pain assessed. Finally, regarding documentation bias, it is well known that pain scores are documented very badly.
A nurse-driven pain protocol based on NRS pain scores increases analgesic administration in the long term and not in the short term. Pain assessment and pain awareness increases immediately. Using IV fentanyl in severe pain seems safe.
Level of evidence 2b
Butti L, Bierti O, Lanfrit R, Bertolini R, Chittaro R, Delli Compagni S, Del Russo D, Mancusi RL, Pertoldi F
Evaluation of the effectiveness and efficiency of the triage emergency department nursing protocol for the management of pain
The authors of this Italian prospective case-series evaluated the use of a previously implemented triage pain protocol in use for patients older than 4 years old and presenting with moderate or severe pain caused by various causes. There was an extensive list of exclusion criteria for use of this protocol, that was based on NRS pain scores (and Wong-Baker scale under the age of 8 years old).
NRS 4-6: Acetaminophen 1000mg orally (body weight > 40kg)
NRS 7-10: morphine 10mg orally administered (Oramorph)
In case children with bodyweight less than 40 kg: acetaminophen dosed per weight category.
The authors found that with this triage pain protocol in place, mean NRS decrease at 60 minutes was > 2 NRS points in 65.9% of 312 patients presenting with a variety of painful conditions. Despite the fact that the majority of patients presented with severe pain (in which morphine was advised by protocol, only 2.6% of patients received this), patient satisfaction regarding analgesic treatment was high (8.73 / 10).
Prospective data collection
As Patient Reported Outcome Measures, not only patient satisfaction in general was measured, but a specific item on analgesic treatment was reported as well.
The inclusion criterion ‘patients whose symptomatology did not suggest surgical intervention’ is a very subjective one and is sensitive to confounding factors, especially of treating staff (both nurses and physicians)
No sample size was performed. The study consisted of only 1 group, without a comparison. Confounding factors, such as crowding or other department- or staff-related factors were not evaluated.
It was not described how long the triage pain protocol had been in place the moment study data was collected.
Regarding the pain protocol, the exclusion list was rather long, raising questions regarding external validity.
A NRS based triage protocol in place utilizing orally administered analgesia and morphine in severe pain decreases pain fast, clinically significant and resulted in high patient satisfaction among patients with a variety of painful conditions, both traumatic and non-traumatic.
Level of evidence 4
This was a prospective before- and after-implementation cohort study in India. The authors tested the hypothesis that implementation of their pain protocol would reduce time to analgesia and provide more pain relief.
The pain protocol that was implemented was both NRS based as well as based on origin of pain. Specific pharmacological recommendations were made when patients presented with abdominal pain; renal colic; fractures and dislocations; acute musculoskeletal injuries; back pain; dental pain; cardiac pain; burn injuries and migraine headache.
Proposed analgesics included IV morphine, fentanyl and acetaminophen; IM diclofenac; nerve blocks and cardiac ischemia medication as well as metoclopramide and haloperidol in migraine. Besides implementation, all emergency physicians were trained in its use, including education regarding pain and pain assessment.
They found that time to analgesia significantly improved and there was greater pain relief after implementation of the protocol in adult patients with mainly abdominal pain, acute musculoskeletal injuries and fractures / dislocations.
The pain protocol that was implemented consisted of both NRS pain scores as well as condition specific analgesic choices, utilizing as much IV administration as possible. Nerve blocks were specifically mentioned.
All patients were recruited prospectively, decreasing information bias.
A formal sample size was performed. Data were collected systematically using standard case report forms.
It is not known how long the pain protocol had been in place at the moment the post-implementation patient group was recruited. A possible 'honeymoon' period could have been present.
Patient satisfaction was measured utilizing the NASS scale. This instrument has been used in measuring pain and disability in patients with spinal conditions. It was probably not validated for use in the acute setting in patients with various causes of pain.
We could not retrieve additional information regarding the E5 scale.
It is not clearly described who collected the data and how these persons were trained or whether they were involved in direct patient care. Therefore, socially desired answers and a Hawthorne effect could not have been ruled out.
Crowding and other departmental factors were not accounted for.
Implementation of a physician's directed pain protocol based on both NRS pain scores and different painful conditions resulted in faster administration of analgesia and superior pain relief.
Level of evidence 2b
Van Zanden JE, Wagenaar S, ter Maaten JM, Ter Maaten JC, Ligtenberg JJM.
Pain score, desire for pain treatment and effect on pain satisfaction in the emergency department: a prospective, observational study
This was a prospective, observational study from The Netherlands. In this study the authors evaluated the effectiveness of a pain protocol that was already in place and investigated decrease in pain scores, patients' satisfaction and explored desires to receive analgesics when presenting to the Emergency Department with pain from various causes.
The pain protocol was NRS based: NRS <4: acetaminophen 1000mg orally; NRS 4-7: acetaminophen 1000mg orally AND naproxen 500mg orally. In case of contra indications for NSAIDs oxycodone 5-10mg orally was used. NRS >7: acetaminophen 1000mg IV AND diclofenac 75mg IV AND piritramide 2mg IV OR fentanyl 50ug IV (if necessary in combination with haloperidol 1mg IV). The goal of pain treatment was set at an NRS decrease of 2-4 NRS points.
They found that pain clinically significantly decreased when protocolized analgesics were administered (decrease 2.41 NRS points). Moreover, it seemed that the initial pain score was the only significant predictor of desiring analgesics in a multivariable analysis.
In case patients denied offered analgesia, this was mainly due to 'bearable pain' and other reasons were that they wanted to know the diagnosis first of had already used pain medication before coming to the Emergency Department. Overall, patients were more satisfied in case they received analgesics compares to patients who did not receive analgesics.
Data were collected prospectively in consecutive patients during a period of 10 days.
Both a univariate (to identify potentially significant factors) and subsequently, a multivariate logistic regression analysis were utilized to identify factors that predicted desire to receive analgesia.
Patient factors were explored by using standardized questionnaires.
This prospective study did not have a formal sample size calculation and it is unknown whether it was powered to detect clinically relevant differences in NRS pain scores.
It is not known how long the pain protocol had been in place and whether a possible 'honeymoon' period could have been present.
Patients were included in case they had pain < 3 months, which seems as a long time, it is not clear how long pain was actually present among participants. Therefore, external validity is questionable.
Research assistants utilizing prospective questionnaires could lead to socially desired answers (from patients' perspective) and a Hawthorne effect (health care staff's perspective).
Emergency Department conditions such a patient crowding were not evaluated.
Patient satisfaction was not specifically measured in pain-related questions and other factors, such as waiting time or communication might have influenced satisfaction.
The study objective was to evaluate effectiveness of the pain protocol, but medication, such as nitroglycerine and proton pump inhibitors were included as well, while not described in the protocol.
The pain protocol that was NRS based seemed effective and resulted in clinically significant decreases in pain scores and increased patient satisfaction. It is important to evaluate patient factors when analgesics are refused, as in this study nearly half of all patients did so.
Level of evidence 2b
The authors of this prospective before- and after-implementation observational study from Israel reported the effects of a nurse-initiated pain protocol. This pain protocol was made for patients presenting with moderate and severe pain (NRS 5 – 10): all patients got offered the combination of dipyrone 1000mg + oxycodone 0.1mg/kg (maximum of 5mg in elderly patients), both orally administered.
In case pain was still scored as moderate or severe after 60 minutes, nurses were allowed to repeat the dose of oxycodone autonomously.
Before using this protocol, all nurses had to attend a 1-hour educational session.
They found that although there was no difference in time to analgesia in general, opioid analgesics were administered significantly faster after implementation, leading to superior pain relief: absolute mean NRS decrease before implementation was 3.34 and after implementation this was 5.7 NRS points. A proportional decrease of 30% in NRS pain scores was achieved in 72.1% after implementation (compared to 44.8% before implementation; p=0.003)
There was a formal sample size calculation reported, powered to detect a difference in NRS decrease of at least 2 NRS points between the before- and after-implementation group.
Patients were recruited prospectively both in the before and after implementation study group.
Although a sample size was performed to detect differences in NRS decrease of 2 points between both groups, it must be noted that at baseline the groups were not identical, as mean NRS at baseline was significantly higher after implementation. This difference was not explained by the authors, nor measures taken to correct this, however it must be said that besides absolute NRS reduction, proportional decreases in NRS pain scores were also reported in order to correct for absolute baseline differences.
Treating nursing staff had to collect study data in case report forms. This could have influenced study results and might have changed nurses’ behavior (compared to a non-study clinical situation).
Implementation of a nurse-initiated orally administered analgesic protocol utilizing a combo of pyridine / oxycodone in all patients with moderate or severe pain resulted in fast and effective pain relief in patients presenting with acute musculoskeletal injuries.
Level of evidence 2b
Minhaj FS, Hoang-Nguyen M, Tenney A, Bragg A, Zhang W, Foster J, Rotoli J, Acquisto NM
Evaluation of opioid requirements in the management of renal colic after guideline implementation in the emergency department
Online ahead of print
In this retrospective cohort study from the USA, the authors evaluated the effect of a multimodal analgesia pain treatment guideline in adult patients with renal colic in the Emergency Department.
This step-wise treatment guideline that was implemented was physician-driven and included:
1. Oral acetaminophen AND IV ketorolac AND 1000mL normal saline fluid bolus
2. IV lidocaine 1.5mg/kg (max 200mg) diluted in 100mL normal saline in 20 minutes
3. Rescue medication IV opioids
Contraindications lidocaine: heart rate <60/min; heart block; arrhythmia; liver failure; allergy to amide anesthetics
The authors mention that patients who were not identified by ICD 10 codes, were identified by IV lidocaine administration as a cross-check.
Data were retrieve by a data collection team (pharmacists and Emergency Medicine residents) and the extraction methods were validated. Very meticulously data collection methods that were tested, optimized and standardized.
The before-implementation period was 1 year and the after-implementation period 9 months, not clear why these were different and whether this difference could have influenced results. No formal sample size calculation was performed.
Stone size was collected from CT or from ultrasound and was not described which method was used in which patients. It must be noted that these methods are not equally sensitive for detecting stones (as small kidney stones and those close to the cortico-medullary junction can be quite hard to find and to measure using ultrasonography).
In the after-implementation group there were significantly more chronic opioid users. This difference might directly have influenced results as treating physicians might not prescribe opioids to opioid users as liberal as to non-chronic opioid users.
One endpoint was incidence of re-presentation. It might be that revisits to other hospitals were missed.
The use of a multimodal analgesia treatment guideline probably decreases opioid requirements in adult patients with renal colic in the Emergency Department and after discharge and the use of lidocaine in such a protocol seems safe. Protocol adherence might be a barrier though.
Level of evidence 2b
Sepahvand M, Gholami M, Hosseinabadi R, Beiranvand A
The use of a nurse-initiated pain protocol in the emergency department for patients with muculoskeletal injury: a pre-post intervention study
The authors from this prospective cohort study from Iran evaluated the use of a nurse-initiated pain management protocol. They divided the study in three phases:
1. Pre-intervention phase, during which triage performance was evaluated by independent researchers evaluating primary assessment, orthopedic assessment and pain management.
2. Intervention phase, consisted of an extensive training program for nursing staff and implementation of the pain management protocol. This protocol was NRS based:
NRS 1-3: acetaminophen 1000mg orally or IV
NRS 4-6: ibuprofen 400mg orally OR tramadol 50mg orally (and acetaminophen if not given yet)
NRS 7-10: morphine 30mg rectal suppository (and acetaminophen if not given yet)
The protocol was implemented over 2 months and posters with the protocol were used to guide implementation. Post-test data collection took place after this period.
A formal sample size calculation was performed (although not sure what for it was powered to detect)
The data collectors and their level of training, as well as methods of data collection were explicitly described (and they did not participated in the care for included patients).
Besides implementation, there were very extensive training sessions for nurses.
The research team explicitly determined content validity and inter-rater reliability of the triage nurses’ performance checklist.
As an exclusion criterion 'reluctance to continue' was mentioned. However, if patients were really excluded from the study when they stopped participating AND were not recorded as included patients, this would have biased study results because of undetected and unrecorded differential loss to follow-up.
In the current study this would have been very relevant, as the 2 questionnaires that were used contained 29 and 12 items. As there was no data presented on how many patients stopped with study participation, this could have biased results in a great way, unknown to us.
Patients were not recruited consecutively and were selected randomly, not specified by whom and whether selection bias could have influenced results.
As data collection was prospective by a research assistant being present (and observing nurses' performance), a Hawthorne effect could not be ruled out.
Prehospital analgesia was not accounted for.
Implementation of a nurse-initiated (non-IV) pain protocol decreased time to analgesia, increased patient satisfaction and resulted in clinically significant decrease in pain scores.
Level of evidence 4
Viglino D, Masson NT, Verdetti A, Champel F, Falcon C, Mouthon A, Makele PM, Muret RC, Dominici CM, Maignan M
Multimodal oral analgesia for non-severe trauma patients: evaluation of a triage-nurse directed protocol combining methoxyflurane, paracetamol and oxycodone
The authors of this French prospective observational study evaluated the effect of a multimodal analgesic nurse-managed pain protocol utilizing acetaminophen, inhaled methoxyflurane and oral oxycodone.
In moderate pain: acetaminophen AND oxycodone 5mg AND inhaled methoxyflurane 3mL (only once during the Emergency Department stay)
In severe pain: the same, but with 10mg oxycodone
They found that this resulted in fast and effective clinically relevant pain relief already at 5 minutes after administration.
Although the authors state that it was safe to use and there were no serious adverse events, it must be emphasized that minor adverse events occurred in almost two/third of all patients. However, mean satisfaction among both patients and staff was rated high.
Data were collected on standard case report forms by research staff, not involved in clinical care.
Sample size calculation was performed in order to detect 80% of patients achieving NRS score of 3 or lower.
The authors aim to evaluate a multimodal analgesia protocol and were the first to explore the use of inhaled methoxyflurane administered by triage nurses.
Patients were not recruited consecutively.
Very extensive list of exclusion criteria, this might decrease external validity.
Although all patients got offered non-pharmacological injury-specific pain treatment (such as icing), it was not explicitly described whether all patients received this.
The implementation of a triage-nurse managed pain protocol utilizing inhaled methoxyflurane together with acetaminophen and oxycodone is feasible to use and effective in fast pain relief. However, the majority of patients experience minor adverse events.
Level of evidence 4