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Recruiting Phase 4 NCT04860141

Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.

Trial Parameters

Condition Dental Pain and Sensation Disorder
Sponsor Loma Linda University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 98
Sex ALL
Min Age 18 Years
Max Age 59 Years
Start Date 2021-06-16
Completion 2026-12
Interventions
Gabapentin 600mgPlacebo

Brief Summary

This study is a double-blind, randomized, prospective, placebo-controlled single-center clinical research study in which 600 mg of gabapentin or placebo will be administered 2 hours preoperatively to 49 patients each undergoing wisdom teeth extraction. We will measure intraoperative opioid use, severity of pain, the number of analgesics taken, and side effect profiles (e.g. nausea/vomiting, dizziness) at the following intervals, 4 hour, 8 hour, 12 hour, 24, and 72 hour post-procedure.

Eligibility Criteria

Inclusion Criteria: * Subjects must be at or older than 18. * Screened body mass index (BMI) between 18-35 kg/m2. * American Society of Anesthesiologists Classification I and II. * Subjects must be willing and able to comply with protocol requirements. * Subjects must be able to understand the informed consent and must be able to sign a written informed consent form prior to the initiation of any study procedures. * A subject must have at least 1 partial or fully impacted third molar tooth removal. Exclusion Criteria: * hypersensitivity to gabapentinoids; * history of chronic opioid or gabapentin usage (regular use of opioids \>3 months) * history of recreational drug usage * a history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, musculoskeletal, psychiatric, or immunologic disorder, any acute, clinically significant illness or condition within 14 days prior to Day 1. * Patients with

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