Introduction: Performance of painful diagnostic and therapeutic procedures is common in emergency department(ED), and procedural sedation and analgesia (PSA) is a fundamental skill for every emergency physician.This studywas aim to compare the efficacy of remifentanil with fentanyl/midazolam in painless reduction of anteriorshoulder dislocation. Methods: In this randomized, double blind, clinical trial the procedural characteristics,patients satisfaction as well as adverse events were compared between fentanyl/midazolamand remifentanilfor PSA of 18–64 years old patients, which were presented to ED following anterior shoulder dislocation.Results: 96 cases were randomly allocated to two groups (86.5% male). There were no significant difference betweengroups regarding baseline characteristics. Remifentanil group had lower duration of procedure (2.5§1.6versus 4.6§1.8 minutes, p Ç 0.001), higher pain reduction (53.7§13.3 versus 33.5§19.6, p Ç 0.001), lower failurerate (1 (2.1%) versus 15 (31.3%), p Ç 0.001), higher satisfaction (p Æ 0.005). Adverse events were seen in 12 (25%)patients in midazolam/fentanyl and 8 (16.7%) cases in remifentanil group (p Æ 0.122). Conclusion: It seemsthat use of remifentanil resulted in lower procedural time, lower failure rate, and lower pain during procedureas well as higher patient satisfaction in comparison with midazolam/fentanyl combination in anterior shoulderdislocation

Gharavifard, Mohammad

Tafakori, Azadeh

Zamani Moghadam, Hamid

English

PubMed

Journals Portal, Shahid Beheshti University of Medical Sciences

Emergency 2016; 4 (2): 92-96ORIGINAL RESEARCHRemifentanil versus Fentanyl/Midazolam in Painless Re-duction of Anterior Shoulder Dislocation; a RandomizedClinical TrialMohammad Gharavifard1, Azadeh Tafakori1∗, Hamid Zamani Moghadam21. Anesthesia Department, Mashhad University of Medical Sciences, Mashhad, Iran.2. Department of Emergency Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.Received: May 2015; Accepted: September 2015Abstract: Introduction: Performance of painful diagnostic and therapeutic procedures is common in emergency depart-ment (ED), and procedural sedation and analgesia (PSA) is a fundamental skill for every emergency physician.This study was aim to compare the efficacy of remifentanil with fentanyl/midazolam in painless reduction of an-terior shoulder dislocation. Methods: In this randomized, double blind, clinical trial the procedural character-istics, patients satisfaction as well as adverse events were compared between fentanyl/midazolam and remifen-tanil for PSA of 18–64 years old patients, which were presented to ED following anterior shoulder dislocation.Results: 96 cases were randomly allocated to two groups (86.5% male). There were no significant difference be-tween groups regarding baseline characteristics. Remifentanil group had lower duration of procedure (2.5±1.6versus 4.6±1.8 minutes, p < 0.001), higher pain reduction (53.7±13.3 versus 33.5±19.6, p < 0.001), lower failurerate (1 (2.1%) versus 15 (31.3%), p < 0.001), higher satisfaction (p = 0.005). Adverse events were seen in 12 (25%)patients in midazolam/fentanyl and 8 (16.7%) cases in remifentanil group (p = 0.122). Conclusion: It seemsthat use of remifentanil resulted in lower procedural time, lower failure rate, and lower pain during procedureas well as higher patient satisfaction in comparison with midazolam/fentanyl combination in anterior shoulderdislocation.Keywords: Conscious sedation; midazolam; fentanyl; remifentanil [supplementary concept]; shoulder dislocation© Copyright (2015) Shahid Beheshti University of Medical SciencesCite this article as: Gharavifard M, Tafakori A, Zamani Moghadam H. Remifentanil versus Fentanyl/Midazolam in Painless Reduction ofAnterior Shoulder Dislocation; a Randomized Clinical Trial. Emergency. 2016; 4(2):92-96.1. IntroductionPerformance of painful diagnostic and therapeutic pro-cedures is common in emergency department (ED),and procedural sedation and analgesia (PSA) is a fun-damental and required skill for every emergency physician(1, 2). With the wide range of procedures and high patientpopulation, the ability to individualize PSA and maximize therisk/benefit ratio for each unique situation is essential (3).One of the common painful procedures in ED is reductionof dislocated shoulder joints. The glenohumeral joint is themost commonly dislocated major joint in the body. The an-∗Corresponding Author: Azadeh Tafakori; Emergency Department, EmamReza Hospital, Mashhad, Iran; Tel: +989173147528; Email: dr.azadeh.tafakori@hotmail.com.nual incidence is 17 per 100,000, and two distinct age peaksare recognized, the first in men 20 to 30 years of age andthe second in older women (4). Analgesia and muscle re-laxation through procedural sedation are often used to facili-tate reduction (5). Fentanyl combined with midazolam is fre-quently used as a safe PSA agent in ED (3). However, cautionmust be exercised when using benzodiazepines and opioidstogether because the risk for hypoxia and apnea is signiïňĄ-cantly greater than when either is used alone (6, 7). Remifen-tanil is a relatively new synthetic opioid with a potencycomparable to fentanyl but an exceptionally short context-sensitive half-life of only 3–5 minutes (8, 9). However, cur-rently there are insufficient published studies to warrant itsroutine use. Efficacy of remifentanil in combination withother agents is supported by several clinical trials (10–14),but few studies have described the use of remifentanil aloneduring performing procedures (15–17). The aim of this ran-This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.com93 Emergency 2016; 4 (2): 92-96domized clinical trial was to compare the efficacy of a pureanalgesia-based sedation regimen with remifentanil with aconventional regimen consisting of fentanyl/midazolam formoderate sedation of patients with anterior shoulder dislo-cation.2. Materials and Methods2.1. Study design and settingsThis study was a prospective, randomized, single-center, par-allel group clinical trial, comparing fentanyl/midazolam toremifentanil alone for moderate sedation in patients aged18–64 years with anterior shoulder dislocation, who werepresented to the ED of Imam Reza Hospital, Mashhad forclosed reduction. This study was approved by the EthicsCommittee of our institute (91/570419 November 4, 2012)and registered in Iranian registry of clinical trials under thenumber IRCT: 2013011312115N1. Informed consent wasobtained from all the selected patients after explaining thestudy.2.2. ParticipantsThe studied subjects were selected using convenience sam-pling among the patients presented to the ED of a university-affiliated tertiary care medical center over a 9-month pe-riod between February 2013 and October 2013, with anteriorshoulder dislocation and requiring closed reduction. Thoseaged 18–64 years with physical condition I (healthy and nor-mal patients without previous medical history) and II (pa-tients with mild systemic disease with no functional limita-tion) according to the classification of American Society ofAnesthesiologists (ASA) were enrolled. All subjects with his-tory of allergy to benzodiazepines and narcotics; prolongeduse of opioids or alcohol; consumption of sedative or anal-gesic drugs before presenting to ED; sleep obstructive apneasyndrome; maxillofacial malformations with high probabil-ity of airway maintenance failure; pregnant; anterior disloca-tion requiring referral to orthopedic operating room; severetrauma and unstable hemodynamics; advanced heart dis-ease; kidney failure; pneumonia; uncontrolled seizures; andfinally patients not willing to participate in the study were ex-cluded.2.3. InterventionUsing convenience sampling 96 patients were randomizedand included in the intention-to-treat analysis, 48 in fen-tanyl/midazolam group and 48 in remifentanil group. Alloca-tion assignments were generated by an online random num-ber generator from http://www.randomizer.org/ andplaced in sealed opaque envelopes to be opened in sequen-tial order by research associates. Physicians (trained senioremergency medicine residents) and patients were blinded tothe type of medication. The investigators doing the analy-sis were not the same as those administering drugs and per-forming the procedures.On arrival to the intervention room, where the requirementsto protect the airway and prevent aspiration as well as thesuitable pulmonary ventilation facilities were predicted, in-travenous access, supplementary oxygen via nasal cannula(2 liter/min), routine pulse oximetry and cardiac monitoringwere established for all the patients. Remifentanil hydrochlo-ride (lyophilized powder in sterile vials each containing 1 mgof the compound) was reconstituted diluted with standarddiluent. The pharmacy at the institute supplied the fentanyland midazolam from commercial stock.The patients in group 1 received remifentanil (1 µg /kg bodyweight bolus intravenous administration at a concentrationof 50 µl/ml , and repeated additional titrated to effect dosesof 1 µg /kg administered every minute until the completionof reduction), while those in group 2 received 1.5 µg /kg fen-tanyl in combination with 0.1 mg /kg midazolam titrated toeffect doses intravenously.It should be noted that in this study, the aim of giving thedrugs was to achieve moderate sedation or conscious seda-tion (Ramsay Sedation score 3), which implied the following:patients only responded to commands; airway interventionwas not necessary; spontaneous ventilation of the patientswas adequate; and the patients cardiovascular function wasmaintained. The amount of drugs to give score 3 sedation,was determined by an attending emergency medicine spe-cialist and the patient was judged to be sedated adequatelyto begin undergoing reduction by him.After sedation, reduction of anterior shoulder was performedby employing traction and counter traction method in bothgroups. Our trained emergency medicine resident rated thepain perceived by the patient before and during the proce-dure using 100 mm visual analog scale (VAS).Demographic data were gathered for all patients. The inci-dence of adverse events was determined by a trained emer-gency medicine resident and was marked in a checklist thatincluded the following: respiratory adverse events (the needfor supplemental oxygen, ventilation with a bag-mask, ma-neuver practices for maintaining the airway open, insertionof airway, respiratory stimulation, and respiratory depres-sion with SpO2 < 92% at any time during intravenous ad-ministration of the drug until hospital discharge), and non-respiratory complications (dysphoria, vomiting, headache,myoclonus, nausea, stiffness, rash, cough, bronchospasm,laryngospasm, stridor, apnea, seizures, restlessness, agita-tion, and aspiration). At the time of discharge, our trainedemergency medicine resident recorded patient satisfactionrate using a Likert scale with four options of excellent, good,average, and poor.This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.comGharavifard et al. 942.4. Study end-pointsThe primary end-points were pain reduction, proceduretime, patient satisfaction, and incidence of respiratoryadverse events. Secondary end-points included non-respiratory adverse events.2.5. DefinitionsA successful reduction was determined clinically by the pres-ence of a palpable clunk, decrease in pain, and improvementin the range of motion.Procedure time was defined as time from start of tractionto completion of reduction. The timing was measured andrecorded using a stopwatch.2.6. Data AnalysisIBM SPSS statistics 21 was used for statistical analyses. Cat-egorical variables were reported as number and percentageand continuous ones as mean ± standard deviation. Chi-square and Fisher exact tests were used for comparing cat-egorical variables and t-test for comparing mean betweengroups. P value < 0.05 was considered statistically signifi-cant.3. Results48 cases received remifentanil and 48 received a combina-tion of fentanyl and midazolam (86.5% male). The mean ageof remifentanil patients was 39.7 ± 10.3 years compared to39.8±9.9 years for fentanyl and midazolam group (p = 0.952).In remifentanil group 41 (85.4%) and in fentanyl and mida-zolam group 42 (87.5%) cases were male (p = 0.5). The sub-jects in both groups were stable regarding hemodynamic sta-tus. The mean pain score at baseline was 70.3±10.8 mm forfentanyl and midazolam and 76.6±11.9 mm for remifentanilgroup (p = 0.008). Since the minimum clinically significantdifference of pain score was considered 30 mm for this study,the baseline difference of pain severity between two groupswas not clinically significant. Table 1 compares the 2 groupsregarding procedure characteristics and observed complica-tions. Respiratory adverse event was not experienced in anyof the groups. Non-respiratory adverse events were seen in12 (25%) patients in midazolam/fentanyl and 8 (16.7%) casesin remifentanil group (p = 0.122).4. DiscussionWhen choosing a strategy for PSA, it is important to considerthe type of procedure being performed (painful or not), thelength of the procedure, specific procedural requirements(anxiolysis vs. immobility), and whether sedation needs tobe prolonged. A risk-benefit analysis should be conductedbefore performing PSA and the benefits of reducing anxietyand pain versus the risk of respiratory depression and airwaydisorders should be measured.The results of the present study demonstrated a significantlylower duration of procedure and lower failure rate in patientsthat were sedated using remifentanil. On the other hand, themean pain reduction was significantly higher in remifentanilgroup. Two groups had the same condition regarding respira-tory and non-respiratory adverse events. The level of patientsatisfaction was significantly higher in remifentanil group.Rai et al. studied remifentanil versus propofol for awakefiberoptic intubation and reported signifcantly shorter en-doscopy and intubation times for remifentanil group (15).Dunn et al. demonstrated that propofol and remifentanilprovide excellent sedation and analgesia for the reductionof anterior glenohumeral dislocation (10, 11). In Phillips etal. case series an initial bolus dosage of 0.5–3 mcg /kg in-travenous remifentanil with subsequent 0.25–1 mcg /kg bo-luses resulted in mean pain severity of 1.1, mean proceduretime of 4 minutes and 17% respiratory complications requir-ing temporary intervention during procedure (16).The lower mean pain severity during the procedure withremifentanil (9.4 ± 8.5 mm vs. 26.1 ± 20.2 mm) revealedgreater effectiveness and potency of this drug. This findingwas similar to Dunn et al., Phillips et al., Swann et al., Sac-chetti et al., and Cok OY et al. findings (10, 12, 13, 16, 17).Some non-respiratory adverse events have been reported us-ing combination of midazolam/fentanyl (18). Application ofremifentanil in combination with midazolam for perform-ing painful procedures in children resulted in high and un-acceptable rate of hypoxemia (14). The incidence of respira-tory and non-respiratory adverse events was similar in bothgroups of the present study.In this study, significantly higher patient satisfaction wasreported for patients sedated with remifentanil, which wascompatible with findings of Dunn et al. (10).In the present study, for eliminating further confounding fac-tors, the same technique of reduction was performed for allpatients in both groups. The study revealed that remifentanilworks effectively in PSA of patients with anterior shoulderdislocation without addition of any sedative agents. Sinceonly adults between the ages of 21 and 64 years were stud-ied, our findings cannot be extrapolated to children and theelderly.5. ConclusionIt seems that use of remifentanil resulted in lower procedu-ral time, lower failure rate, and lower pain during procedureas well as higher patient satisfaction in comparison with mi-dazolam/fentanyl combination for procedural sedation andanalgesia in anterior shoulder dislocation. The 2 groups hadthe same condition regarding respiratory and non-espiratoryThis open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.com95 Emergency 2016; 4 (2): 92-96Table 1: Comparison of the 2 studied groups regarding procedure characteristics and observed complicationsVariable Fentanyl + Midazolam Remifentanil P valueMean procedure time (minute) 4.6±1.8 2.5±1.6 < 0.001Pain severity during procedure# 36.8±22.9 22.9±9.9 < 0.001Mean pain reduction 33.5±19.6 53.7±13.3 < 0.001Failure rate 15 (31.3) 1 (2.1) < 0.001Non-respiratory adverse eventsVomiting 2 (4.2) 0 (0) 0.247Nausea 5 (10.4) 1 (2.1) 0.102Itching 2 (4.2) 5 (10.4) 0.218Cough 2 (4.2) 1 (2.1) 0.5Agitation 1 (1.2) 0 (0) 0.5Dysphoria 4 (8.3) 2 (4.2) 0.339Total 12 (25) 8 (16.7) 0.122Patient satisfactionExcellent 32 (66.7) 43 (89.6) < 0.005Good 16 (33.3) 5 (10.4)Values are presented in mean ± standard deviation or number (%), pain severity was measured based on visual analogue scale (mil-limeter), failure rate: failure in pain reduction ≥ 30 mm.adverse events.6. Appendix6.1. AcknowledgementsThe authors appreciate the insightful cooperation of Emer-gency Department staff.6.2. Author contributionAll authors passed four criteria for authorship contributionbased on recommendations of the International Committeeof Medical Journal Editors.6.3. FundingNone.6.4. Conflict of interestNone.References1. Cordell WH, Keene KK, Giles BK, Jones JB, Jones JH,Brizendine EJ. The high prevalence of pain in emer-gency medical care. The American journal of emergencymedicine. 2002;20(3):165–9.2. Godwin SA, Caro DA, Wolf SJ, et al. Clinical policy: pro-cedural sedation and analgesia in the emergency depart-ment. Annals of emergency medicine. 2005;45(2):177–96.3. Marx J, Walls R, Hockberger R. Rosen’s EmergencyMedicine-Concepts and Clinical Practice: ElsevierHealth Sciences; 2013. p.4. Chalidis B, Sachinis N, Dimitriou C, Papadopoulos P,Samoladas E, Pournaras J. Has the management of shoul-der dislocation changed over time? 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Remifentanil versus Fentanyl/Midazolam in Painless Reduction of Anterior Shoulder Dislocation; a Randomized Clinical Trial

Mohammad Gharavifard

Azadeh Tafakori

Hamid Zamani Moghadam

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Remifentanil versus Fentanyl/Midazolam in Painless Reduction of Anterior Shoulder Dislocation; a Randomized Clinical Trial

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