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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01332253

Public ClinicalTrials.gov record NCT01332253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 2:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01332253
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cumberland Pharmaceuticals
Industry
Enrollment
161 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2011
Primary completion
Jun 30, 2012
Completion
Jul 31, 2012
Last update posted
Nov 2, 2016

2011 – 2012

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Advanced ENT & Allergy Louisville Kentucky 40207
University Hospital, University of Medicine and Dentistry NJ Newark New Jersey 07101
Southeastern Clinical Research Associates Charlotte North Carolina 28210
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
Comprehensive Pain Specialists Hendersonville Tennessee 37075
Baylor College of Medicine/Texas Children's Hospital Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01332253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2016 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01332253 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →