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

Phase 4

• Conditions: Otitis Media; Pain, Postoperative
• Interventions: Drug: Fentanyl; Drug: Ketorolac

• Registration Number: NCT02653742
• Lead Sponsor: Anica Crnkovic

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-10
• Study First Posted: 2016-01-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-13
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.
Ketorolac	Ketorolac	Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.
Ketorolac and Fentanyl	Ketorolac	Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.
Ketorolac and Fentanyl	Fentanyl	Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

Primary Outcome Measures

Name	Time	Method
Pain score assessment	Through study completion, an average of 1 hour postop	Pain assessment score using CHEOPS

Secondary Outcome Measures

Name	Time	Method
Administration of additional pain medication	Through study completion, an average of 1 hour postop	The need for additional pain medication other than the study medication to control postoperative pain

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States