Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

Summary

This prospective, randomized, double blinded study is designed to compare the bleeding rates of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients ages 2-18.

Timeline

Start

2017-11-21

Primary completion

2022-11-01

Completion

2022-11-01

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 Chan DK, Parikh SR. Perioperative ketorolac increases post-tonsillectomy hemorrhage in adults but not children. Laryngoscope. 2014 Aug;124(8):1789-93. doi: 10.1002/lary.24555. Epub 2014 May 27.
• Background Riggin L, Ramakrishna J, Sommer DD, Koren G. A 2013 updated systematic review & meta-analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-inflammatory agents on the risk of bleeding after tonsillectomy. Clin Otolaryngol. 2013 Apr;38(2):115-29. doi: 10.1111/coa.12106.
• Background Lee WT, Witsell DL, Parham K, Shin JJ, Chapurin N, Pynnonen MA, Langman A, Nguyen-Huynh A, Ryan SE, Vambutas A, Roberts RS, Schulz K. Tonsillectomy Bleed Rates across the CHEER Practice Research Network: Pursuing Guideline Adherence and Quality Improvement. Otolaryngol Head Neck Surg. 2016 Jul;155(1):28-32. doi: 10.1177/0194599816630523.
• Background Windfuhr JP, Chen YS, Remmert S. Hemorrhage following tonsillectomy and adenoidectomy in 15,218 patients. Otolaryngol Head Neck Surg. 2005 Feb;132(2):281-6. doi: 10.1016/j.otohns.2004.09.007.
• Background Lane JC, Dworkin-Valenti J, Chiodo L, Haupert M. Postoperative tonsillectomy bleeding complications in children: A comparison of three surgical techniques. Int J Pediatr Otorhinolaryngol. 2016 Sep;88:184-8. doi: 10.1016/j.ijporl.2016.07.007. Epub 2016 Jul 11.
• Background Bailey R, Sinha C, Burgess LP. Ketorolac tromethamine and hemorrhage in tonsillectomy: a prospective, randomized, double-blind study. Laryngoscope. 1997 Feb;107(2):166-9. doi: 10.1097/00005537-199702000-00006.
• Background Judkins JH, Dray TG, Hubbell RN. Intraoperative ketorolac and posttonsillectomy bleeding. Arch Otolaryngol Head Neck Surg. 1996 Sep;122(9):937-40. doi: 10.1001/archotol.1996.01890210017004.
• Background Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
• Background Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736.
• Background Ketorolac., Drug Facts and Comparisons 4.0 (online). I. Wolters Kluwer Health, Editor. 2011.
• Background Ketorolac. National Cancer Institute Drug Dictionary.
• Background Gupta A, Daggett C, Ludwick J, Wells W, Lewis A. Ketorolac after congenital heart surgery: does it increase the risk of significant bleeding complications? Paediatr Anaesth. 2005 Feb;15(2):139-42. doi: 10.1111/j.1460-9592.2005.01409.x.
• Background Aldrink JH, Ma M, Wang W, Caniano DA, Wispe J, Puthoff T. Safety of ketorolac in surgical neonates and infants 0 to 3 months old. J Pediatr Surg. 2011 Jun;46(6):1081-5. doi: 10.1016/j.jpedsurg.2011.03.031.
• Background Papacci P, De Francisci G, Iacobucci T, Giannantonio C, De Carolis MP, Zecca E, Romagnoli C. Use of intravenous ketorolac in the neonate and premature babies. Paediatr Anaesth. 2004 Jun;14(6):487-92. doi: 10.1111/j.1460-9592.2004.01250.x.
• Background Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.
• Background Cohen MN, Christians U, Henthorn T, Vu Tran Z, Moll V, Zuk J, Galinkin J. Pharmacokinetics of single-dose intravenous ketorolac in infants aged 2-11 months. Anesth Analg. 2011 Mar;112(3):655-60. doi: 10.1213/ANE.0b013e3182075d04. Epub 2011 Jan 13.
• Background Pappas AL, Fluder EM, Creech S, Hotaling A, Park A. Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg. 2003 Jun;96(6):1621-1624. doi: 10.1213/01.ANE.0000064206.51296.1D.
• Background Zuppa AF, Mondick JT, Davis L, Cohen D. Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther. 2009 Mar-Apr;16(2):143-6. doi: 10.1097/MJT.0b013e31818071df.
• Background Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.
• Background Gupta A, Daggett C, Drant S, Rivero N, Lewis A. Prospective randomized trial of ketorolac after congenital heart surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):454-7. doi: 10.1053/j.jvca.2004.05.024.
• Background Perez-Urizar J, Aguilar-Cota ME, Herrera JE, Flores-Murrieta FJ. Comparative bioavailability of ketorolac tromethamine after intramuscular and sublingual administration. Proc West Pharmacol Soc. 2002;45:6-7. No abstract available.
• Background Drover DR, Hammer GB, Anderson BJ. The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. Anesth Analg. 2012 Jun;114(6):1270-6. doi: 10.1213/ANE.0b013e31824f92c2. Epub 2012 Mar 30.
• Background Lieh-Lai MW, Kauffman RE, Uy HG, Danjin M, Simpson PM. A randomized comparison of ketorolac tromethamine and morphine for postoperative analgesia in critically ill children. Crit Care Med. 1999 Dec;27(12):2786-91. doi: 10.1097/00003246-199912000-00030.
• Background Forrest JB, Heitlinger EL, Revell S. Ketorolac for postoperative pain management in children. Drug Saf. 1997 May;16(5):309-29. doi: 10.2165/00002018-199716050-00003.
• Background 26. Ketorolac: Peds Dosing. 2017: Epocrates.
• Background 27. Ketorolac Dosage. Drugs.com.
• Background Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.
• Background Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.

Drugs

Indications

No indication recorded.