Pregabalin vs. Gabapentin on Reducing Opioid Usage

Pain Clinical Trial

Official title:

Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705480
• Other study ID #: 20-718
• Status: Recruiting
• Phase: Phase 4
• Start date: April 12, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: CAMC Health System
• Contact: John A DeLuca, MD
• Phone: 3043887278
• Email: john.deluca[@]camc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesics
• Gabapentin
• Injuries
• Narcotics
• Pain
• Trauma
• Wounds and Injuries

Intervention

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).
• 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).
• Neither Pregabalin nor Gabapentin
Patients will receive neither Pregabalin nor Gabapentin.

Locations

Country	Name	City	State
United States	Charleston Area Medical Center"s Level 1 Trauma Center	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in opioid usage	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.	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary	Incentive spirometry values	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.	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary	Rate of intubation	To compare the proportion of patients requiring intubation among the study groups.	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary	Pain control	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."	First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
Secondary	Hospital length of stay	To evaluate the differences among the study arms with respect to hospital length of stay (days).	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary	Rate of unplanned ICU admission	To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.	First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment