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

NCT04860141 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 5200474
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• opioid use

  assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.

  4 hour postoperatively

• opioid use

  assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.

  8 hour postoperatively

• opioid use

  assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.

  12 hour postoperatively

• opioid use

  assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.

  48 hour postoperatively

• opioid use

  assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.

  72 hour postoperatively

• intraoperative fentanyl use

  assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case.

  during the surgical procedure

Secondary Outcomes (16)

• pain control

  4 hour postoperatively

• pain control

  8 hour postoperatively

• pain control

  12 hour postoperatively

• pain control

  24 hour postoperatively

• pain control

  48 hour postoperatively

Study Arms (2)

Gabapentin group

EXPERIMENTAL

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

Drug: Gabapentin 600mg

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gabapentin 600mg DRUG

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

Gabapentin group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You 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 may not qualify 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (8)

• Turan A, Memis D, Karamanlioglu B, Yagiz R, Pamukcu Z, Yavuz E. The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. Anesth Analg. 2004 Aug;99(2):375-8, table of contents. doi: 10.1213/01.ANE.0000136646.11737.7B.

  PMID: 15271709 BACKGROUND

• Salama ER, Amer AF. The effect of pre-emptive gabapentin on anaesthetic and analgesic requirements in patients undergoing rhinoplasty: A prospective randomised study. Indian J Anaesth. 2018 Mar;62(3):197-201. doi: 10.4103/ija.IJA_736_17.

  PMID: 29643553 BACKGROUND

• Han C, Li XD, Jiang HQ, Ma JX, Ma XL. The use of gabapentin in the management of postoperative pain after total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016 Jun;95(23):e3883. doi: 10.1097/MD.0000000000003883.

  PMID: 27281103 BACKGROUND

• Grover VK, Mathew PJ, Yaddanapudi S, Sehgal S. A single dose of preoperative gabapentin for pain reduction and requirement of morphine after total mastectomy and axillary dissection: randomized placebo-controlled double-blind trial. J Postgrad Med. 2009 Oct-Dec;55(4):257-60. doi: 10.4103/0022-3859.58928.

  PMID: 20083871 BACKGROUND

• Crisologo PA, Monson EK, Atway SA. Gabapentin as an Adjunct to Standard Postoperative Pain Management Protocol in Lower Extremity Surgery. J Foot Ankle Surg. 2018 Jul-Aug;57(4):781-784. doi: 10.1053/j.jfas.2018.02.005. Epub 2018 May 7.

  PMID: 29748103 BACKGROUND

• Felder L, Saccone G, Scuotto S, Monks DT, Carvalho JCA, Zullo F, Berghella V. Perioperative gabapentin and post cesarean pain control: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:98-106. doi: 10.1016/j.ejogrb.2018.11.026. Epub 2018 Dec 12.

  PMID: 30583095 BACKGROUND

• Quintero GC. Review about gabapentin misuse, interactions, contraindications and side effects. J Exp Pharmacol. 2017 Feb 9;9:13-21. doi: 10.2147/JEP.S124391. eCollection 2017.

  PMID: 28223849 BACKGROUND

• Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26.

  PMID: 27459955 BACKGROUND

MeSH Terms

Conditions

Toothache; Sensation Disorders; Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Chi Viet, DDS MD PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je Dong Ryu, DMD MD

CONTACT

909-558-4423; jryu@llu.edu

Sung Han, DDS MD

CONTACT

909-558-4423; shan@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: * Only the allocator knows the computer generated randomization scheme and this will be strictly controlled. The allocator will not be directly involved in the patient care. * The allocator will also pre-package a pill in a small bag so that a distributor does not know which medication is being given to the patient. * Gabapentin and placebo pills will be formulated by an investigational pharmacist to ensure both pills are identical in shape and form to further reduce bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: June 16, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)