Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children
NCT02653742 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2021-09-13
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).
Conditions
- Pain, Postoperative
- Otitis Media
Interventions
- DRUG
-
Ketorolac
Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.
- DRUG
-
Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia
Sponsors & Collaborators
-
Anica Crnkovic
lead OTHER
Principal Investigators
-
Anica Crnkovic, MD · Albany Medical College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Months
- Max Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- United States
Study Locations
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