At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 161 enrolled
Drug / intervention
Intravenous ibuprofen +1 moredrug
Likely dose
Intravenous ibuprofen 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Intravenous ibuprofen and Normal Saline for Tonsillectomy. Completed, enrolled 161 participants across 6 sites.
Detailed Summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTonsillectomy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartJul 2011
Primary CompletionJul 2012
Study CompletionAug 2012
TodayJul 2026
First PostedApr 11, 2011
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.2 years ago
Interventions
Intravenous ibuprofendrug
Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
Normal Salineother
Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.