Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

Pain, Postoperative Clinical Trial

Official title:

Prospective, Randomized, Allocation-Concealed, Blinded Study Designed to Compare Ketorolac Sublingual and Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02653742
• Other study ID #: 3943
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Albany Medical College
• Contact: Farzana Afroze, MD
• Phone: 518-262-4300
• Email: afrozef[@]mail.amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (BMTs).

Description:

This prospective, randomized, allocation concealed blinded study is designed to compare ketorolac sublingual vs. fentanyl intranasal vs. the combination of these two medications for pain control after BMTs in children. Bilateral myringotomy and tube placement is an elective operation, mainly in the pediatric population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 7 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) I-II physical class

• Scheduled for elective BMT

• Mask induction of anesthesia

Exclusion Criteria:

• Allergy to any NSAIDs

• Severe upper respirator infection

• Severe asthma

• Bleeding disorders

• History of GI bleeding

• Renal impairment

• Scheduled for one-sided myringotomy and tube placement

Related Conditions & MeSH terms

• Otitis Media
• Pain, Postoperative

Intervention

Drug:
• Ketorolac
Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.
• Fentanyl
Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Anica Crnkovic

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. — View Citation

Finkel JC, Cohen IT, Hannallah RS, Patel KM, Kim MS, Hummer KA, Choi SS, Pena M, Schreiber SB, Zalzal G. The effect of intranasal fentanyl on the emergence characteristics after sevoflurane anesthesia in children undergoing surgery for bilateral myringotomy tube placement. Anesth Analg. 2001 May;92(5):1164-8. — View Citation

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Galinkin JL, Fazi LM, Cuy RM, Chiavacci RM, Kurth CD, Shah UK, Jacobs IN, Watcha MF. Use of intranasal fentanyl in children undergoing myringotomy and tube placement during halothane and sevoflurane anesthesia. Anesthesiology. 2000 Dec;93(6):1378-83. — View Citation

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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. — View Citation

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. — View Citation

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. Erratum in: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pérez-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. — View Citation

Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score assessment	Pain assessment score using CHEOPS	Through study completion, an average of 1 hour postop
Secondary	Administration of additional pain medication	The need for additional pain medication other than the study medication to control postoperative pain	Through study completion, an average of 1 hour postop