Introduction: Finding a fast-acting compound with minimal side-effects to induce a safe and efficient analgesia with short or medium duration of action is of great interest in the emergency department. The present study has been designed with the aim of comparing the effect of midazolam + fentanyl + lidocaine combination with midazolam + fentanyl + placebo in pain management of anterior shoulder dislocation reduction.
Methods: The present two-arm parallel double-blind randomized controlled trial was performed on patients who presented to emergency department with anterior shoulder dislocation. Patients were randomly allocated to the 2 treatment groups of midazolam + fentanyl + placebo (double-drug group) and midazolam + fentanyl + intravenous (IV) lidocaine (triple-drug group). Then outcomes such as treatment success rate and side-effects following prescription of drugs were compared between the 2 groups.
Results: 100 patients were included in the present study (50 patients in each group; mean age of the studied patients 27.3±8.9 years; 93.0% male). Using the double-drug regimen led to 35 (70%) cases of complete analgesia, while this rate in the triple-drug group was 41 (82%) cases (p=0.16). The calculated number needed to treat was 9 cases. This means that about one in every 9 patients in treatment arm will benefit from the treatment. The most important side-effects observed included dysrhythmia (1 patient in double drug and 1 patient in triple-drug group), apnea (2 patients in each group) and SPO2<90% (2 patients in triple-drug group) (p=0.78). Number needed to harm was 25 cases. In other words, for each 25 patients treated with the triple drug regimen, 1 case of SPO2<90% is observed.Conclusion: Findings of the present study showed that adding IV lidocaine to IV midazolam + fentanyl drug combination does not provide additional analgesia in sedation for anterior shoulder reduction.
Chalidis B, Sachinis N, Dimitriou C, Papadopoulos P, Samoladas E, Pournaras J. Has the management of shoulder dislocation changed over time? International orthopaedics. 2007;31(3):385-9.
Kanji A, Atkinson P, Fraser J, Lewis D, Benjamin S. Delays to initial reduction attempt are associated with higher failure rates in anterior shoulder dislocation: a retrospective analysis of factors affecting reduction failure. Emerg Med J. 2015:emermed-2015-204746.
Tezel O, Kaldirim U, Bilgic S, Deniz S, Eyi YE, Ozyurek S, et al. A comparison of suprascapular nerve block and procedural sedation analgesia in shoulder dislocation reduction. The American journal of emergency medicine. 2014;32(6):549-52.
Jiang N, Hu Y-j, Zhang K-r, Zhang S, Bin Y. Intra-articular lidocaine versus intravenous analgesia and sedation for manual closed reduction of acute anterior shoulder dislocation: an updated meta-analysis. Journal of clinical anesthesia. 2014;26(5):350-9.
Innes G, Murphy M, Nijssen–Jordan C, Ducharme J, Drummond A. Procedural sedation and analgesia in the emergency department. Canadian Consensus Guidelines. Journal of Emergency Medicine. 1999;17(1):145-56.
Bellolio MF, Gilani WI, Barrionuevo P, Murad MH, Erwin PJ, Anderson JR, et al. Incidence of adverse events in adults undergoing procedural sedation in the emergency department: a systematic review and meta‐analysis. Academic Emergency Medicine. 2016;23(2):119-34.
Grunwell JR, Marupudi NK, Gupta RV, Travers CD, McCracken CE, Williamson JL, et al. Outcomes following implementation of a pediatric procedural sedation guide for referral to general anesthesia for magnetic resonance imaging studies. Pediatric Anesthesia. 2016;26(6):628-36.
Green RS, Butler MB, Campbell SG, Erdogan M. Adverse events and outcomes of procedural sedation and analgesia in major trauma patients. Journal of emergencies, trauma, and shock. 2015;8(4):210.
Azizkhani R, Esmailian M, Shojaei A, Golshani K. Rectal Thiopental versus Intramuscular Ketamine in Pediatric Procedural Sedation and Analgesia; a Randomized Clinical Trial. Emergency (Tehran, Iran). 2015;3(1):22-6.
Azizkhani R, Kanani S, Sharifi A, Golshani K, Masoumi B, Ahmadi O. Oral Chloral Hydrate Compare with Rectal Thiopental in Pediatric Procedural Sedation and Analgesia; a Randomized Clinical Trial. Emergency (Tehran, Iran). 2014;2(2):85-9.
Barzegari H, Masoumi K, Motamed H, Zohrevandi B, Zeynadini Meymand S. Comparing Two Different Doses of Intravenous Midazolam in Pediatric Sedation and Analgesia. Emergency (Tehran, Iran). 2016;4(4):192-5.
Barzegari H, Zohrevandi B, Masoumi K, Forouzan A, Darian AA, Khosravi S. Comparison of Oral Midazolam and Promethazine with Oral Midazolam alone for Sedating Children during Computed Tomography. Emergency (Tehran, Iran). 2015;3(3):109-13.
Gharavifard M, Boroumand Reza Zadeh B, Zamani Moghadam H. A Randomized Clinical Trial of Intravenous and Intramuscular Ketamine for Pediatric Procedural Sedation and Analgesia. Emergency (Tehran, Iran). 2015;3(2):59-63.
Gharavifard M, Tafakori A, Zamani Moghadam H. Remifentanil versus Fentanyl/Midazolam in Painless Reduction of Anterior Shoulder Dislocation; a Randomized Clinical Trial. Emergency (Tehran, Iran). 2016;4(2):92-6.
Jalili M, Bahreini M, Doosti-Irani A, Masoomi R, Arbab M, Mirfazaelian H. Ketamine-propofol combination (ketofol) vs propofol for procedural sedation and analgesia: systematic review and meta-analysis. Am J Emerg Med. 2016;34(3):558-69.
Nejati A, Moharari RS, Ashraf H, Labaf A, Golshani K. Ketamine/propofol versus midazolam/fentanyl for procedural sedation and analgesia in the emergency department: a randomized, prospective, double-blind trial. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2011;18(8):800-6.
Raeyat Doost E, Heiran MM, Movahedi M, Mirafzal A. Ultrasound-guided interscalene nerve block vs procedural sedation by propofol and fentanyl for anterior shoulder dislocations. Am J Emerg Med. 2017;35(10):1435-9.
Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. The Cochrane database of systematic reviews. 2005(4):Cd003345.
de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Revista brasileira de anestesiologia. 2010;60(3):325-33.
Groudine SB, Fisher HA, Kaufman RP, Jr., Patel MK, Wilkins LJ, Mehta SA, et al. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesthesia and analgesia. 1998;86(2):235-9.
Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, et al. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesthesia and analgesia. 2004;98(4):1050-5, table of contents.
Hames H, Millard WM. Use of intra-articular lidocaine as analgesia in anterior shoulder dislocation: a review and meta-analysis of the literature. Canadian Journal of Rural Medicine. 2009;14(4):145.
Binnekade JM, Vroom MB, de Vos R, de Haan RJ. The reliability and validity of a new and simple method to measure sedation levels in intensive care patients: a pilot study. Heart & lung : the journal of critical care. 2006;35(2):137-43.
Kim K-T, Cho D-C, Sung J-K, Kim Y-B, Kang H, Song K-S, et al. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. The Spine Journal. 2014;14(8):1559-66.
Fitzpatrick BM, Mullins ME. Intravenous lidocaine for the treatment of acute pain in the emergency department. Clinical and experimental emergency medicine. 2016;3(2):105.