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Pregabalin vs. Gabapentin for Pain Management

Phase 4

Recruiting

Research Sponsored by CAMC Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Active order(s) for opioids in place at the time of enrollment

Must not have

CrCl<30ml/min or on HD

History of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trialtests different meds to reduce opioid use in people with orthopedic trauma.

Who is the study for?

This trial is for adults over 18 who have been admitted to a Nurse Practitioner service with single-system orthopedic trauma, need opioids, and will stay in the hospital for more than a day. It's not for those with brain injuries, complex wounds, severe kidney issues, trouble swallowing pills, intubation, epilepsy history or substance use disorder.

What is being tested?

The study compares Pregabalin (50mg) and Gabapentin (300mg) to see if they can help reduce opioid usage when given alongside standard painkillers after orthopedic trauma. Patients are randomly assigned to one of these drugs or no drug at all.

What are the potential side effects?

Possible side effects from Pregabalin and Gabapentin may include dizziness, sleepiness, swelling of hands/feet or blurred vision. They might also cause difficulty concentrating which could affect the ability to perform tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently prescribed opioids.

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I expect to stay in the hospital for more than a day after giving consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is very low or I am on dialysis.

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I have a history of epilepsy.

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I cannot take medications by mouth.

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I have an epidural.

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I am taking pregabalin or gabapentin.

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I have had issues with wound healing after surgery.

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I take pregabalin or gabapentin as part of my daily medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment for reporting.