CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 109 enrolled
Drug / intervention
Pregabalin 50mg +2 moredrug
Likely dose
Pregabalin 50mgfrom 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.

Search/NCT04705480
NCT04705480Phase 4Completed

Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients

CAMC Health System·interventional·Posted Jan 12, 2021·Updated Jan 6, 2026

In Brief

A Phase 4 clinical trial evaluating Pregabalin 50mg, Gabapentin 300mg, and 1 other intervention for Analgesics and 5 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed Summary

This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 12, 2021
Enrollment StartApr 12, 2021
Primary CompletionSep 30, 2024
Study CompletionDec 13, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.5 years ago

Interventions

Pregabalin 50mgdrug

Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).

Gabapentin 300mgdrug

Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).

Neither Pregabalin nor Gabapentindrug

Patients will receive neither Pregabalin nor Gabapentin.