Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries

Summary

Acute limb injury is a common reason to visit an emergency department worldwide. Intense pain related to the injury is always a concern for an emergency physician and requires effective analgesia within the shortest possible time. Non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol are the commonly used drugs in an emergency department. The choice of analgesia should be established by its efficacy, logistics involved and route of administration. There is good evidence about NSAIDs being the first line analgesia and paracetamol is reported to have the narcotic sparing effect, either alone or as an adjunctive treatment in different settings. The synergistic effect of paracetamol with diclofenac in acute limb injuries related pain management lacks good- quality evidence. Therefore investigators proposed a large, well designed, randomized double-blind trial to develop high-quality evidence. The study aims to assess the efficacy of paracetamol in addition to diclofenac, and compare the difference between oral and intravenous paracetamol administration in acute limb injuries in the emergency department.

Timeline

Start

2022-10-16

Primary completion

2023-02-21

Completion

2023-02-21

Publications

• Background Tramer MR, Williams JE, Carroll D, Wiffen PJ, Moore RA, McQuay HJ. Comparing analgesic efficacy of non-steroidal anti-inflammatory drugs given by different routes in acute and chronic pain: a qualitative systematic review. Acta Anaesthesiol Scand. 1998 Jan;42(1):71-9. doi: 10.1111/j.1399-6576.1998.tb05083.x.
• Background Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.
• Results Aarons L, Ogungbenro K. Optimal design of pharmacokinetic studies. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):250-5. doi: 10.1111/j.1742-7843.2009.00533.x. Epub 2010 Jan 20.
• Results Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
• Results Macintyre PE, Schug SA, Scott DA. Acute pain management: the evidence grows. Med J Aust. 2006 Feb 6;184(3):101-2. doi: 10.5694/j.1326-5377.2006.tb00144.x.
• Results Tveita T, Thoner J, Klepstad P, Dale O, Jystad A, Borchgrevink PC. A controlled comparison between single doses of intravenous and intramuscular morphine with respect to analgesic effects and patient safety. Acta Anaesthesiol Scand. 2008 Aug;52(7):920-5. doi: 10.1111/j.1399-6576.2008.01608.x.
• Results Tuomilehto H, Kokki H. Parenteral ketoprofen for pain management after adenoidectomy: comparison of intravenous and intramuscular routes of administration. Acta Anaesthesiol Scand. 2002 Feb;46(2):184-9. doi: 10.1034/j.1399-6576.2002.460211.x.
• Results Hindle A, Spedding R. Managing acute renal colic. Intramuscular diclofenac should be avoided. BMJ. 2003 Mar 1;326(7387):502. doi: 10.1136/bmj.326.7387.502. No abstract available.
• Results Wright PJ, English PJ, Hungin AP, Marsden SN. Managing acute renal colic across the primary-secondary care interface: a pathway of care based on evidence and consensus. BMJ. 2002 Dec 14;325(7377):1408-12. doi: 10.1136/bmj.325.7377.1408. No abstract available.
• Results Moran CP, Courtney AE. Managing acute and chronic renal stone disease. Practitioner. 2016 Feb;260(1790):17-20, 2-3.
• Results Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
• Results Babl FE, Theophilos T, Palmer GM. Is there a role for intravenous acetaminophen in pediatric emergency departments? Pediatr Emerg Care. 2011 Jun;27(6):496-9. doi: 10.1097/PEC.0b013e31821d8629.
• Results Serinken M, Eken C, Turkcuer I, Elicabuk H, Uyanik E, Schultz CH. Intravenous paracetamol versus morphine for renal colic in the emergency department: a randomised double-blind controlled trial. Emerg Med J. 2012 Nov;29(11):902-5. doi: 10.1136/emermed-2011-200165. Epub 2011 Dec 20.
• Results Craig M, Jeavons R, Probert J, Benger J. Randomised comparison of intravenous paracetamol and intravenous morphine for acute traumatic limb pain in the emergency department. Emerg Med J. 2012 Jan;29(1):37-9. doi: 10.1136/emj.2010.104687. Epub 2011 Mar 1.
• Results Bektas F, Eken C, Karadeniz O, Goksu E, Cubuk M, Cete Y. Intravenous paracetamol or morphine for the treatment of renal colic: a randomized, placebo-controlled trial. Ann Emerg Med. 2009 Oct;54(4):568-74. doi: 10.1016/j.annemergmed.2009.06.501. Epub 2009 Jul 31.
• Results Grissa MH, Claessens YE, Bouida W, Boubaker H, Boudhib L, Kerkeni W, Boukef R, Nouira S. Paracetamol vs piroxicam to relieve pain in renal colic. Results of a randomized controlled trial. Am J Emerg Med. 2011 Feb;29(2):203-6. doi: 10.1016/j.ajem.2009.09.019. Epub 2010 Oct 8.
• Results Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
• Results Olonisakin RP, Amanor-Boadu SD, Akinyemi AO. Morphine-sparing effect of intravenous paracetamol for post operative pain management following gynaecological surgery. Afr J Med Med Sci. 2012 Dec;41(4):429-36.
• Qureshi I, S Qureshi R, Harris T, A Pathan S, Malik AME, Babiker ME, Jamali MA, Bhutta ZA, Thomas SH. A Randomized Trial Evaluating the Synergistic Effect of Parenteral Diclofenac and Paracetamol for Pain Management in Adult Males With Acute Limb Injury. Pain Res Manag. 2026 Jan 31;2026:5587917. doi: 10.1155/prm/5587917. eCollection 2026.

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