Pregabalin vs. Gabapentin on Reducing Opioid Usage

Phase 4

Recruiting

• Conditions: Gabapentin; Pain; Trauma; Analgesics; Narcotics; Injuries
• Interventions: Drug: Pregabalin 50mg; Drug: Neither Pregabalin nor Gabapentin; Drug: Gabapentin 300mg

• Registration Number: NCT04705480
• Lead Sponsor: CAMC Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Study Start: 2021-04-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Nurse Practitioner service admissions
2. 18 years of age or older
3. Patients enrolled within 36 hours of admission
4. Anticipated duration of hospitalization > 24 hours from time of consent
5. Active order(s) for opioids in place at the time of enrollment

Exclusion Criteria

1. Clinician discretion based on patient care management
2. Intubated patients
3. Patients with epidural
4. Patients with pregabalin/gabapentin as home medications
5. Patients receiving pregabalin/gabapentin upon admission
6. Traumatic brain injury patients
7. CrCl<30ml/min or on HD
8. Unable to take enteral medications
9. On Patient Controlled Analgesia (PCA)
10. Patients with complicated wound closure
11. History of epilepsy
12. Documented history of substance use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin 50mg	-
Neither Pregabalin nor Gabapentin	Neither Pregabalin nor Gabapentin	-
Gabapentin	Gabapentin 300mg	-

Primary Outcome Measures

Name	Time	Method
Reduction in opioid usage	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment	To determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.

Secondary Outcome Measures

Name	Time	Method
Rate of intubation	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment	To compare the proportion of patients requiring intubation among the study groups.
Incentive spirometry values	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment	To compare the change in documented incentive spirometry values (liters) from morning physical assessment among patients in each of the study groups who have at least 1 rib fracture.
Hospital length of stay	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment	To evaluate the differences among the study arms with respect to hospital length of stay (days).
Pain control	First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment	To assess effectiveness of pain control in each arm based on the average Numeric Pain Rating Scale score per 24 hours. This scale is a 10 point numeric scale that ranges from 0 that represents "no pain" to 10 which indicates the "worst pain imaginable."
Rate of unplanned ICU admission	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment	To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.

Trial Locations

Locations (1)

Charleston Area Medical Center"s Level 1 Trauma Center; 🇺🇸 Charleston, West Virginia, United States