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Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03453541
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Farzana Afroze, Albany Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Analgesic Adverse Reaction Drug: Ketorolac Tromethamine Drug: Saline Solution Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: CRNAs, PACU nurses, and participants are all blinded
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Ketorolac
This group receives Ketorolac 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use, 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Drug: Ketorolac Tromethamine
Ketorolac 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use, 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.

Placebo Comparator: Saline
This group will receive an equivalent weight-based volume of 0.9% NaCl solution at the completion of the tonsillectomy in the operating room.
Drug: Saline Solution
Normal saline 0.5 mg/kg IV bolus at the completion of the tonsillectomy in the operating room.




Primary Outcome Measures :
  1. Rebleeding rates requiring operative intervention [ Time Frame: 2 weeks post-operative ]

Secondary Outcome Measures :
  1. PACU admission and discharge time [ Time Frame: Immediately after operation ]
  2. Post-operative pain medication requirements [ Time Frame: Immediately after operation ]
  3. Post-operative pain scores [ Time Frame: Immediately after operation ]
  4. Post-operative nausea/vomiting [ Time Frame: Immediately after operation ]
  5. Emergency room visits/admissions [ Time Frame: 2 weeks post-operative ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-ASA physical status I to III, age of 2 years to 18 years old (inclusive) scheduled for elective tonsillectomy with or without adenoidectomy.

Exclusion Criteria:

-Exclusion criteria are: allergy to any nonsteroidal anti-inflammatory medications, bleeding disorders, history of gastrointestinal bleeding, renal impairment, severe asthma, cardiac/hepatic disease, use of anticoagulation, recent NSAID use (within last 72 hours) or any other medical problem that in the opinion of investigator would interfere with study participation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453541


Contacts
Contact: Farzana Afroze, MD 518-262-3125 AfrozeF@amc.edu

Locations
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Farzana Afroze, MD    518-262-3125    AfrozeF@amc.edu   
Sub-Investigator: Eric P Zhou, MD         
Sub-Investigator: Carolyn DeBiase, MD         
Sub-Investigator: Melissa Ehlers, MD         
Sub-Investigator: Sakina Rangwala, MD         
Sub-Investigator: Jason Mouzakes, MD         
Sub-Investigator: Patrick Savery, DO         
Sub-Investigator: Anica Crnkovic, MD         
Sub-Investigator: Helena Oechsner, MD         
Sub-Investigator: Yarnell LaFortune, MD         
Sub-Investigator: Igor Galay, MD         
Sub-Investigator: : Pragnyadipta Mishra, MBBS         
Sponsors and Collaborators
Albany Medical College

Publications:
1. Baugh, R.F., et al., Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg, 2011. 144(1 Suppl): p. S1-30. 2. Chan, D.K. and S.R. Parikh, Perioperative ketorolac increases post-tonsillectomy hemorrhage in adults but not children. Laryngoscope, 2014. 124(8): p. 1789-93. 3. Riggin, L., et al., 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. Clinical Otolaryngology, 2013. 38(2): p. 115-129. 4. Lee, W.T., et al., Tonsillectomy Bleed Rates across the CHEER Practice Research Network: Pursuing Guideline Adherence and Quality Improvement. Otolaryngol Head Neck Surg, 2016. 155(1): p. 28-32. 5. Windfuhr, J.P., Y.S. Chen, and S. Remmert, Hemorrhage following tonsillectomy and adenoidectomy in 15,218 patients. Otolaryngol Head Neck Surg, 2005. 132(2): p. 281-6. 6. Lane, J.C., et al., Postoperative tonsillectomy bleeding complications in children: A comparison of three surgical techniques. Int J Pediatr Otorhinolaryngol, 2016. 88: p. 184-8. 7. Bailey, R., C. Sinha, and L.P. Burgess, Ketorolac tromethamine and hemorrhage in tonsillectomy: a prospective, randomized, double-blind study. Laryngoscope, 1997. 107(2): p. 166-9. 8. Judkins, J.H., T.G. Dray, and R.N. Hubbell, Intraoperative ketorolac and posttonsillectomy bleeding. Arch Otolaryngol Head Neck Surg, 1996. 122(9): p. 937-40. 9. Aldrete, J.A. and D. Kroulik, A postanesthetic recovery score. Anesth Analg, 1970. 49(6): p. 924-34. 10. Moodie, J.E., et al., The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg, 2008. 107(6): p. 2025-31. 11. Ketorolac. , in Drug Facts and Comparisons 4.0 (online). I. Wolters Kluwer Health, Editor. 2011.
12. Ketorolac. National Cancer Institute Drug Dictionary. 13. Gupta, A., et al., Ketorolac after congenital heart surgery: does it increase the risk of significant bleeding complications? Paediatr Anaesth, 2005. 15(2): p. 139-42. 14. Aldrink, J.H., et al., Safety of ketorolac in surgical neonates and infants 0 to 3 months old. J Pediatr Surg, 2011. 46(6): p. 1081-5. 15. Papacci, P., et al., Use of intravenous ketorolac in the neonate and premature babies. Paediatr Anaesth, 2004. 14(6): p. 487-92. 16. Lynn, A.M., et al., Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth, 2011. 21(3): p. 325-34. 17. Cohen, M.N., et al., Pharmacokinetics of single-dose intravenous ketorolac in infants aged 2-11 months. Anesth Analg, 2011. 112(3): p. 655-60.
18. Pappas, A.L., et al., Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg, 2003. 96(6): p. 1621-4, table of contents. 19. Zuppa, A.F., et al., Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther, 2009. 16(2): p. 143-6. 20. Neri, E., et al., 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. 98(9): p. 721-4. 21. Gupta, A., et al., Prospective randomized trial of ketorolac after congenital heart surgery. J Cardiothorac Vasc Anesth, 2004. 18(4): p. 454-7. 22. Perez-Urizar, J., et al., Comparative bioavailability of ketorolac tromethamine after intramuscular and sublingual administration. Proc West Pharmacol Soc, 2002. 45: p. 6-7. 23. Drover, D.R., G.B. Hammer, and B.J. Anderson, The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. Anesth Analg, 2012. 114(6): p. 1270-6. 24. Lieh-Lai, M.W., et al., A randomized comparison of ketorolac tromethamine and morphine for postoperative analgesia in critically ill children. Crit Care Med, 1999. 27(12): p. 2786-91. 25. Forrest, J.B., E.L. Heitlinger, and S. Revell, Ketorolac for postoperative pain management in children. Drug Saf, 1997. 16(5): p. 309-29. 26. Ketorolac: Peds Dosing. 2017: Epocrates. 27. Ketorolac Dosage. Drugs.com. 28. Lynn, A.M., et al., Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg, 2007. 104(5): p. 1040-51, tables of contents. 29. Liu, Y., et al., A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth, 2013. 23(12): p. 1187-92.

Responsible Party: Farzana Afroze, Assistant Professor of Anesthesiology, Albany Medical College
ClinicalTrials.gov Identifier: NCT03453541     History of Changes
Other Study ID Numbers: 4923
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action