drugset / Trial / NCT02133326
Efficacy Study of IV Ibuprofen vs IV Acetaminophen Post Surgical Extraction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when compared to single dose of IV acetaminophen in reducing pain. We will administer this study medication thirty minutes prior to removal of wisdom teeth. We want to see if administering these drugs prior to surgery may reduce post-operative pain. Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during surgery will reduce postoperative pain following third molar extraction when compared to the acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less opioid medications compared to those receiving preemptive acetaminophen.
Timeline
- Start
- 2014-03
- Primary completion
- 2017-01
- Completion
- 2017-01
Publications
- Background Hargreaves KM, Troullos ES, Dionne RA. Pharmacologic rationale for the treatment of acute pain. Dent Clin North Am. 1987 Oct;31(4):675-94.
- Background Dionne RA, Khan AA, Gordon SM. Analgesia and COX-2 inhibition. Clin Exp Rheumatol. 2001 Nov-Dec;19(6 Suppl 25):S63-70.
- Background Gordon SM, Brahim JS, Rowan J, Kent A, Dionne RA. Peripheral prostanoid levels and nonsteroidal anti-inflammatory drug analgesia: replicate clinical trials in a tissue injury model. Clin Pharmacol Ther. 2002 Aug;72(2):175-83. doi: 10.1067/mcp.2002.126501.
- Background Ridgway D. Analgesics for acute pain: Meeting the United States Food and Drug Administration's requirements for proof of efficacy. Clin J Pain. 2004 May-Jun;20(3):123-32. doi: 10.1097/00002508-200405000-00001.
- Background Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.
- Background Arici S, Gurbet A, Turker G, Yavascaoglu B, Sahin S. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009 Apr;21(2):54-61.
- Background Borisov, D Preemptive analgesia with paracetamol in postoperative analgesia for abdominal surgery: 14AP5-2 European Journal of Anaesthesiology: June 2007 - Volume 24 - Issue - p 179
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | Intravenous |
| Subject | Ibuprofen | Small molecule | 800 mg | Intravenous |