What this study is
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.
What's being tested
- Gabapentin 600mg
Intervention · DRUG
The patient will take gabapentin 600mg 2 hours prior to the procedure
- Placebo
Intervention · DRUG
the patient will take a pill that looks like gabapentin 2 hours prior to the procedure
Study details
- Official title
- Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
- Sponsor
- Loma Linda University
- Conditions
- Dental Pain and Sensation Disorder · Pain, Postoperative
- Enrolling
- 98 people
- Starts
- 2021-06-16
- Est. completion
- 2026-12
- Design
- Triple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 59 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLoma Linda University Health
Loma Linda, California, United States
Recruiting
Study team
Sponsor
Loma Linda University
Study ID 5200474
Principal investigator
Chi Viet, DDS MD PhD
Loma Linda University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.