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Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

NCT01332253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-11-03

Study results available
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Summary

The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.

Conditions

  • Tonsillectomy

Interventions

DRUG

Intravenous ibuprofen

Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.

OTHER

Normal Saline

Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Art P Wheeler, MD · Cumberland Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT01332253 on ClinicalTrials.gov