At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 240 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 75 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.
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management
In Brief
A Phase 3 clinical trial evaluating Pregabalin and Sugar pill for Delirium and Pain. Completed, enrolled 240 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.
Study Details
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartMay 2009
Primary CompletionSep 2011
Study CompletionOct 2011
TodayJul 2026
First PostedJan 9, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.5 years ago
Interventions
Pregabalindrug
Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function
Sugar pillother
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively