Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
NCT ID: NCT04199572
Last Updated: 2023-03-01
Study Results
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Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2022-10-16
2023-02-21
Brief Summary
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Detailed Description
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Most patients with acute limb injuries are treated with, the commonly used analgesics like non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol in the ED. The choice of analgesic should be established by its efficacy, logistics involved, and route of drug administration. Few studies reported that intravenous route is more effective than the intramuscular route, due to its faster absorption and ease of titration. In many ED's intramuscular injectable drugs like NSAIDs are commonly used. Being, readily available and technically faster to administer. There is concern about the use of IM diclofenac in some countries because of possible intramuscular complications; however, most are reported cases in a small proportion (\<2 per million doses used). Oral medications are also very commonly used and usually self-administered by the patients with duration of onset being in minutes to an hour. There is good evidence about NSAIDs being the first line analgesic in the management of acute painful conditions such as renal colic. Intramuscular diclofenac is shown to provide safe, effective, and sustained pain relief in addition to being logistically easier to administer. Paracetamol being a centrally acting inhibitor of cyclooxygenases has been reported safe alternative to opioids and equally effective analgesic in the ED with fewer side effects and contraindications. In addition, paracetamol is reported to have the narcotic sparing effect, either alone or as an adjunctive treatment in different settings including post-op pain, cancer pain, and regional anesthesia. The synergistic effect of paracetamol with diclofenac in acute limb injury related- pain management lacks good-quality evidence.
Hamad General Hospital Emergency Department (HGH-ED) is the major emergency department (ED) in Doha; Qatar; and offers tertiary level care for emergency conditions. It is also one of the busiest ED's in the world with an annual patient attendance of 0.5 million. Patients with acute limb injuries account for about 25% of the total ED visits. At HGH-ED, intramuscular diclofenac is the analgesia of choice for the management of acute pain of moderate to severe intensity. However, 40-50% of these patients require additional analgesia in the form of opioids or paracetamol. The efficacy of combined analgesia approach, and the difference by route of drug administration in acute ED pain management is yet to be assessed. Therefore investigators proposed a large, well designed, randomized, double- blind trial to develop high-quality evidence. This 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 injury pain management in the ED.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diclofenac and Oral Paracetamol
Diclofenac (75mg intramuscular), Placebo (100ml intravenous Normal Saline), Paracetamol (per oral 1gm)
Diclofenac and Paracetamol
analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
Diclofenac and IV Paracetamol
Diclofenac (75mg intramuscular), Paracetamol (intravenous1gm in 100ml solution), Placebo (sugar tablets)
Diclofenac and Paracetamol
analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
Diclofenac and Placebo
Diclofenac (75mg intramuscular),Placebo (100ml intravenous Normal Saline),Placebo (sugar tablets)
Diclofenac and Paracetamol
analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
Interventions
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Diclofenac and Paracetamol
analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vitals Stable
* musculoskeletal limb injury
* initial pain score of 5 or more on a NRS (numerical rating scale)
Exclusion Criteria
* Allergies to either diclofenac or paracetamol
* Contraindication to the study drugs
* CVA
* Bronchial asthma
* GI bleeding
* Renal impairment
* Asthma
* Pregnancy and nursing
* Unstable traumatic patient
18 Years
65 Years
ALL
Yes
Sponsors
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Hamad Medical Corporation
INDUSTRY
Responsible Party
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Dr. Isma Qureshi
Academic Research Associate
Locations
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Hamad Medical Corporation
Doha, , Qatar
Countries
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References
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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.
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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.
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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.
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.
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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.
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.
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.
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.
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.
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.
Other Identifiers
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IRGC-04-NI-17-099
Identifier Type: -
Identifier Source: org_study_id
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