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Pregabalin vs. Gabapentin on Reducing Opioid Usage

NCT04705480 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-01-06

Study results available
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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.

Conditions

  • Analgesics
  • Gabapentin
  • Injuries
  • Narcotics
  • Pain
  • Trauma

Interventions

DRUG

Pregabalin 50mg

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).

DRUG

Gabapentin 300mg

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).

DRUG

Neither Pregabalin nor Gabapentin

Patients will receive neither Pregabalin nor Gabapentin.

Sponsors & Collaborators

  • West Virginia Clinical and Translational Science Institute

    collaborator OTHER

  • CAMC Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2024-09-30
Completion
2024-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705480 on ClinicalTrials.gov