Pregabalin vs. Gabapentin on Reducing Opioid Usage

Study Overview
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Brief Summary
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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.

Official Title
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Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients

Conditions
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Analgesics, Gabapentin, Injuries, Narcotics, Pain, Trauma

Intervention / Treatment
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* Drug: Pregabalin 50mg
* Drug: Gabapentin 300mg
* Drug: Neither Pregabalin nor Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nurse Practitioner service admissions 18 years of age or older Patients enrolled within 36 hours of admission Anticipated duration of hospitalization > 24 hours from time of consent Active order(s) for opioids in place at the time of enrollment Exclusion Criteria: Clinician discretion based on patient care management Intubated patients Patients with epidural Patients with pregabalin/gabapentin as home medications Patients receiving pregabalin/gabapentin upon admission Traumatic brain injury patients CrCl<30ml/min or on HD Unable to take enteral medications On Patient Controlled Analgesia (PCA) Patients with complicated wound closure History of epilepsy Documented history of substance use disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: Pregabalin 50mg<br>* 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).<br>* Other names: Lyrica;|
| Experimental: Gabapentin<br> | Drug: Gabapentin 300mg<br>* 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).<br>* Other names: Neurontin;|
| Active Comparator: Neither Pregabalin nor Gabapentin<br> | Drug: Neither Pregabalin nor Gabapentin<br>* Patients will receive neither Pregabalin nor Gabapentin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregabalin , ,, Gabapentin, Opioid Pain Medication Use, Trauma, Opioid Usage Reduction