Recruiting

Gabapentin

Sponsor:

Loma Linda University

Code:

NCT04860141

Conditions

Dental Pain and Sensation Disorder

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

Gabapentin 600mg

Placebo

Study Details

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.

Conditions

Dental Pain and Sensation Disorder

Pain, Postoperative

Study ID

NCT04860141

Start date

Jun 16, 2021

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gabapentin group

The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery.

placebo comparator: Placebo group

The patient in this group will take a placebo that looks like gabapentin PO 2 hours prior to his or her surgery.

Interventions

Gabapentin 600mg

The patient will take gabapentin 600mg 2 hours prior to the procedure

Placebo

the patient will take a pill that looks like gabapentin 2 hours prior to the procedure

Primary outcome measure

  • opioid use [ Time Frame: 4 hour postoperatively ]
  • opioid use [ Time Frame: 8 hour postoperatively ]
  • opioid use [ Time Frame: 12 hour postoperatively ]
  • opioid use [ Time Frame: 48 hour postoperatively ]
  • opioid use [ Time Frame: 72 hour postoperatively ]
  • intraoperative fentanyl use [ Time Frame: during the surgical procedure ]

Central Contacts and Locations

Central contacts

Je Dong Ryu, DMD MD

909-558-4423jryu@llu.edu

Sung Han, DDS MD

909-558-4423shan@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

More Information

Sponsor

Loma Linda University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • gabapentin
  • third molar extraction
  • postoperative pain
  • intraoperative pain
  • opioid reduction
  • narcotic reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-02-04.