Comparing Pregabalin and Gabapentin to Reduce Opioid Use in Trauma Patients
Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
This study is testing if the medications Pregabalin and Gabapentin can help trauma patients use fewer opioids for pain relief while they are in the hospital.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CAMC Health System Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT04705480 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Pregabalin and Gabapentin in reducing opioid medication usage among patients with orthopedic trauma. It is a single-center, randomized, open-label Phase 4 trial where participants will receive either Pregabalin, Gabapentin, or no additional medication alongside traditional opioid pain management. The study aims to enroll patients within 36 hours of admission who are expected to stay in the hospital for more than 24 hours and have active opioid orders. The goal is to determine if these medications can help decrease reliance on opioids for pain management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted for orthopedic trauma and have active opioid orders.
Not a fit: Patients with a history of substance use disorder or those who are intubated or on Patient Controlled Analgesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced opioid consumption and lower the risk of opioid-related side effects and dependency in trauma patients.
How similar studies have performed: Other studies have explored the use of Pregabalin and Gabapentin for pain management, showing promising results in reducing opioid use, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, West Virginia
- Charleston Area Medical Center"s Level 1 Trauma Center — Charleston, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: John A DeLuca, MD
- Email: john.deluca@camc.org
- Phone: 3043887278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.