NCT02653742

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Anica Crnkovic · Academic / Other
• Sex: All
• Age: 8 Months – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Otitis Media

Interventions

Type	Name	Description
DRUG	Ketorolac	Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.
DRUG	Fentanyl	Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia

Timeline

• Start date: 2015-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-01-12
• Last updated: 2021-09-13

Locations

1 site across 1 country: United States