At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 100 enrolled
Drug / intervention
Acetaminophen +1 moredrug
Likely dose
Acetaminophen 1000 mgfrom 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.
The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
The University of Texas Health Science Center, Houston·interventional·Posted May 15, 2012·Updated Jun 19, 2018
In Brief
A Phase 4 clinical trial evaluating Acetaminophen and Placebo for Postoperative Pain. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
CollaboratorsMallinckrodt
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedMay 2012
Primary CompletionMar 2016
TodayJul 2026
First PostedMay 15, 2012
Enrollment StartMay 2, 2012
Primary CompletionMar 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.1 years ago
Interventions
Acetaminophendrug
Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.
Placebodrug
100 mL 0.9% Sodium Chloride