RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.

Quick Facts

Study Start:2021-06-16
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04860141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must be at or older than 18.
  2. * Screened body mass index (BMI) between 18-35 kg/m2.
  3. * American Society of Anesthesiologists Classification I and II.
  4. * Subjects must be willing and able to comply with protocol requirements.
  5. * 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.
  6. * A subject must have at least 1 partial or fully impacted third molar tooth removal.
  1. * hypersensitivity to gabapentinoids;
  2. * history of chronic opioid or gabapentin usage (regular use of opioids \>3 months)
  3. * history of recreational drug usage
  4. * 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.
  5. * Patients with baseline pain.
  6. * Patients with any oral pathology will be excluded.
  7. * Pregnant or breastfeeding patients
  8. * An individual not legally competent to consent (e.g., incapacitated individuals, incompetents, minors)

Contacts and Locations

Study Contact

Je Dong Ryu, DMD MD
CONTACT
909-558-4423
jryu@llu.edu
Sung Han, DDS MD
CONTACT
909-558-4423
shan@llu.edu

Principal Investigator

Chi Viet, DDS MD PhD
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma Linda University Health
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Chi Viet, DDS MD PhD, PRINCIPAL_INVESTIGATOR, Loma Linda University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-16
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-06-16
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Dental Pain and Sensation Disorder
  • Pain, Postoperative