Using gabapentin before wisdom teeth removal to reduce pain and opioid use
Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
This study tests if taking gabapentin before getting your wisdom teeth removed can help manage pain and reduce the need for opioids during recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT04860141 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of administering 600 mg of gabapentin two hours before wisdom teeth extraction to reduce intraoperative and postoperative opioid use while managing pain. It is a double-blind, randomized, placebo-controlled study involving 49 patients, who will be monitored for pain severity, opioid consumption, and side effects at various intervals post-surgery. The goal is to determine if gabapentin can provide adequate pain control and minimize reliance on opioids during recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require the removal of at least one impacted third molar and have a BMI between 18-35.
Not a fit: Patients with a history of chronic opioid or gabapentin use, hypersensitivity to gabapentinoids, or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption and improve pain management for patients undergoing wisdom teeth extraction.
How similar studies have performed: Previous studies in other surgical specialties have shown promising results for gabapentin in reducing opioid use, but this specific application in oral and maxillofacial surgery is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Chi Viet, DDS MD PhD — Loma Linda University
- Study coordinator: Je Dong Ryu, DMD MD
- Email: jryu@llu.edu
- Phone: 909-558-4423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.