Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
Loma Linda University
98 participants
Jun 16, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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)
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Interventions
The patient will take gabapentin 600mg 2 hours prior to the procedure
the patient will take a pill that looks like gabapentin 2 hours prior to the procedure
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04860141