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NCT01332253 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
A Phase 3 study of Tonsillectomy, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
- 6
- Study locations
NCT01332253: Completed Phase 3 study of Tonsillectomy, sponsored by Cumberland Pharmaceuticals.
NCT01332253 is a Phase 3 study of Tonsillectomy that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 161 participants, below the 1,766-participant average among 6 other Tonsillectomy trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332253, a Phase 3 study of Tonsillectomy, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
- 6
- Study locations
Study Summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
Primary Outcome
To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.
Conditions Studied
Interventions
- OTHER Normal Saline
- DRUG Intravenous ibuprofen
Study Locations (6)
Kentucky
- Advanced ENT & Allergy - Louisville
New Jersey
- University Hospital, University of Medicine and Dentistry NJ - Newark
North Carolina
- Southeastern Clinical Research Associates - Charlotte
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Tennessee
- Comprehensive Pain Specialists - Hendersonville
Texas
- Baylor College of Medicine/Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01332253 record still lists
NCT01332253 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 1,766-participant average among 6 other Tonsillectomy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Tonsillectomy appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT01332253 lists 6 locations in 6 states (Kentucky, New Jersey, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01332253 about?
NCT01332253 is a clinical study titled "Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy". The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
What is the current status of trial NCT01332253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2011-07. Estimated completion is 2012-08.
What conditions does trial NCT01332253 study?
This clinical trial studies the following conditions: Tonsillectomy.
What interventions are being tested in trial NCT01332253?
The interventions under investigation include: Normal Saline (OTHER), Intravenous ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01332253?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01332253 being conducted?
This trial has 6 study locations across Kentucky, New Jersey, North Carolina, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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