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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653742 on ClinicalTrials.gov