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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Loma Linda University
• Treatments: Gabapentin

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 baseline pain.

• Patients with any oral pathology will be excluded.

• Pregnant or breastfeeding patients

• An individual not legally competent to consent (e.g., incapacitated individuals, incompetents, minors)