NCT01332253

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2011-04-11
• Last updated: 2016-11-03
• Results posted: 2016-11-03

Locations

6 sites across 1 country: United States