drugset / Trial / NCT03385057
Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy
Phase 1
Withdrawn
Massachusetts Eye and Ear Infirmary
Emory University · collabMadigan Army Medical Center · collabRady Children's Hospital, San Diego · collabUnited States Naval Medical Center, Portsmouth · collabUniversity Hospitals Cleveland Medical Center · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Pediatric tonsillectomy is one of the most common surgical procedures annually in the United States; risks include postoperative hemorrhage and poor pain control. Controversy exists regarding optimal pharmacologic pain management following surgery, as each drug's efficacy is balanced by its specific side effects. Ibuprofen is effective in controlling postoperative pain following tonsillectomy, but its mechanism of action results in decreased platelet function, which may increase postoperative bleeding events. This is a multicenter, randomized control non-inferiority trial designed to assess the relationship between short-course ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.
Timeline
- Start
- 2018-09
- Primary completion
- 2023-01-01
- Completion
- 2023-01-01
Publications
- Background Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
- Background Boss EF, Marsteller JA, Simon AE. Outpatient tonsillectomy in children: demographic and geographic variation in the United States, 2006. J Pediatr. 2012 May;160(5):814-9. doi: 10.1016/j.jpeds.2011.11.041. Epub 2011 Dec 17.
- Background Alexander NS, Schroeder JW Jr. Pediatric obstructive sleep apnea syndrome. Pediatr Clin North Am. 2013 Aug;60(4):827-40. doi: 10.1016/j.pcl.2013.04.009.
- Background Schwengel DA, Dalesio NM, Stierer TL. Pediatric obstructive sleep apnea. Anesthesiol Clin. 2014 Mar;32(1):237-61. doi: 10.1016/j.anclin.2013.10.012.
- Background Spicuzza L, Leonardi S, La Rosa M. Pediatric sleep apnea: early onset of the 'syndrome'? Sleep Med Rev. 2009 Apr;13(2):111-22. doi: 10.1016/j.smrv.2008.07.001. Epub 2008 Dec 5.
- Background Randall DA, Hoffer ME. Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg. 1998 Jan;118(1):61-8. doi: 10.1016/S0194-5998(98)70376-6.
- Background Subramanyam R, Varughese A, Willging JP, Sadhasivam S. Future of pediatric tonsillectomy and perioperative outcomes. Int J Pediatr Otorhinolaryngol. 2013 Feb;77(2):194-9. doi: 10.1016/j.ijporl.2012.10.016. Epub 2012 Nov 16.
- Background Tan GX, Tunkel DE. Control of Pain After Tonsillectomy in Children: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Sep 1;143(9):937-942. doi: 10.1001/jamaoto.2017.0845.
- Background Cohen N, Sommer DD. Post-tonsillectomy pain control: consensus or controversy? Pain Manag. 2016;6(1):31-7. doi: 10.2217/pmt.15.58. Epub 2015 Dec 17.
- Background Moir MS, Bair E, Shinnick P, Messner A. Acetaminophen versus acetaminophen with codeine after pediatric tonsillectomy. Laryngoscope. 2000 Nov;110(11):1824-7. doi: 10.1097/00005537-200011000-00011.
- Background Isaacson G. Pediatric tonsillectomy: an evidence-based approach. Otolaryngol Clin North Am. 2014 Oct;47(5):673-90. doi: 10.1016/j.otc.2014.06.011. Epub 2014 Aug 7.
- Background Isaacson G. Tonsillectomy care for the pediatrician. Pediatrics. 2012 Aug;130(2):324-34. doi: 10.1542/peds.2011-3857. Epub 2012 Jul 2.
- Background Romsing J, Hertel S, Harder A, Rasmussen M. Examination of acetaminophen for outpatient management of postoperative pain in children. Paediatr Anaesth. 1998;8(3):235-9. doi: 10.1046/j.1460-9592.1998.00768.x.
- Background Zubieta JK, Smith YR, Bueller JA, Xu Y, Kilbourn MR, Jewett DM, Meyer CR, Koeppe RA, Stohler CS. Regional mu opioid receptor regulation of sensory and affective dimensions of pain. Science. 2001 Jul 13;293(5528):311-5. doi: 10.1126/science.1060952.
- Background Sadhasivam S, Myer CM 3rd. Preventing opioid-related deaths in children undergoing surgery. Pain Med. 2012 Jul;13(7):982-3; author reply 984. doi: 10.1111/j.1526-4637.2012.01419.x. Epub 2012 Jun 13.
- Background Whittaker MR. Opioid use and the risk of respiratory depression and death in the pediatric population. J Pediatr Pharmacol Ther. 2013 Oct;18(4):269-76. doi: 10.5863/1551-6776-18.4.269.
- Background Burian M, Geisslinger G. COX-dependent mechanisms involved in the antinociceptive action of NSAIDs at central and peripheral sites. Pharmacol Ther. 2005 Aug;107(2):139-54. doi: 10.1016/j.pharmthera.2005.02.004. Epub 2005 Apr 19.
- Background Goldenberg NA, Jacobson L, Manco-Johnson MJ. Brief communication: duration of platelet dysfunction after a 7-day course of Ibuprofen. Ann Intern Med. 2005 Apr 5;142(7):506-9. doi: 10.7326/0003-4819-142-7-200504050-00009.
- Background Rainsford KD. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology. 2009 Dec;17(6):275-342. doi: 10.1007/s10787-009-0016-x. Epub 2009 Nov 21.
- Background St Charles CS, Matt BH, Hamilton MM, Katz BP. A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient. Otolaryngol Head Neck Surg. 1997 Jul;117(1):76-82. doi: 10.1016/S0194-59989770211-0.
- Background Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
- Background Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications. Otolaryngol Head Neck Surg. 1998 Nov;119(5):492-6. doi: 10.1016/S0194-5998(98)70107-X.
- Background Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 15 mg/kg | — |
| Comparator | Ibuprofen | Small molecule | 10 mg/kg | — |
Indications
No indication recorded.