Pregabalin vs. Gabapentin on Reducing Opioid Usage
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Pregabalin
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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).
Other Names:
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Experimental: Gabapentin
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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).
Other Names:
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Active Comparator: Neither Pregabalin nor Gabapentin
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Drug: Neither Pregabalin nor Gabapentin
Patients will receive neither Pregabalin nor Gabapentin.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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."
- 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).
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Nurse Practitioner service admissions
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18 to 65 year of age
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Patients enrolled within 24 hours of admission
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Anticipated duration of hospitalization > 24 hours from time of consent
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Active order(s) for opioids in place at the time of enrollment
Exclusion Criteria:
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Clinician discretion based on patient care management
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Intubated patients
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Patients with epidural
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Patients with pregabalin/gabapentin as home medications
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Patients receiving pregabalin/gabapentin upon admission
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Traumatic brain injury patients
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CrCl<30ml/min or on HD
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Unable to take enteral medications
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On Patient Controlled Analgesia (PCA)
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Patients with complicated wound closure
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History of epilepsy
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Documented history of substance use disorder
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Charleston Area Medical Center"s Level 1 Trauma Center | Charleston | West Virginia | United States | 25301 |
Sponsors and Collaborators
- CAMC Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-718