Clinical trial NCT04860141: Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
Official title: Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dental Pain and Sensation Disorder
Pain, Postoperative
Keywords: gabapentin
third molar extraction
postoperative pain
intraoperative pain
opioid reduction
narcotic reduction
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Since the 1990s, the amount of prescribed opioids has begun growing. According to the Center for Disease Control, more than 130 people die every day due to opioid overdose. Many medical and surgical specialities have devised various methods to decrease opioid use with adequate pain control. One notable method is preoperative administration of gabapentin. Gabapentin, a prescribed medication, is an anticonvulsant medication used to treat partial seizures, neuropathic pain (e.g.

diabetic neuropathy, postherpetic neuralgia, and central neuropathic pain), hot flashes, and restless legs syndrome . Various surgical specialties such as otolaryngology, plastics, general surgery, obstetrics/gynecology have tested the efficacy of gabapentin in reducing postoperative opioid usage without compromising pain control and the result is promising. However, this study has not been done in oral and maxillofacial surgery. The objectives of the study is to determine if preoperative administration of gabapentin can decrease intraoperative and postoperative use of opioid and provide adequate pain control when used with non-opioid pain regimen.

On the day of consultation visit, subjects will be screened and evaluated by oral and maxillofacial surgery residents. Those who meet the inclusion criteria will be enrolled in the study. They will then be randomly divided into following groups:

* Group 1a: 49 subjects undergoing wisdom teeth extraction will be receiving 600mg gabapentin PO preoperatively
* Group 1b: 49 subjects undergoing wisdom teeth extraction will be receiving placebo PO preoperatively.

A subject then will be given a small bag that contains either a gabapentin pill or a placebo pill depending on which group that he or she is assigned to. The subject will be asked to take 600mg of gabapentin or a placebo pill 2 hours prior to their procedure (vs. current standard of care is no pre-medication). On the day of the procedure, they will be accompanied by a guardian or a family member to the clinic. The Procedure will be done by a senior or a chief level resident with supervision of an attending surgeon. Intraoperative opioid use will be recorded on a standardized anesthesia sheet. All cases will include IV sedation that involves a concoction of fentanyl, midazolam, propofol, ketamine, and dexamethasone. The medications will be given in boluses depending on their weight but not necessarily strictly kg-based. For example, fentanyl will be given between 25 -50mcg, midazolam 2.5-5mg, propofol 10-40mg and ketamine 10-50mg. Local anesthesia with 2% lidocaine with 1:100,000 epinephrine will also be given after sedation. Additional doses of local anesthetic can be given if the patient experiences sharp pain. Additional doses of propofol and/or fentanyl can be given if the patient's systolic blood pressure increases by 10 mmHg or heart rate increases by 20 bpm acutely. All used anesthetics will be recorded. After the procedure, standard postoperative pain regimen will be prescribed including 28 tablets of ibuprofen 600mg PO q6h prn pain and 12 tablets of Norco 5/325mg PO q6h prn pain with an instruction to take Norco only when a subject is in severe pain (pain level greater than 7 out of 10). To assess the severity of pain and its impact on functioning, scientists developed Brief Pain Inventory from which Modified Brief pain inventory (MBPI) was created to better fit the need for our research; MBPI will not only ask the severity of pain but also 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. The patient is to turn in the MBPI form during their 1 week postoperative follow up visit. If for any reason, the patient misses the follow up appointment, we will try to reschedule their visit within 5 days. If the patient does not show up at all, our members will find out the reason for the no show and record it for the publication purpose.

Eligibility 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)

Primary outcomes:
measure: opioid use
timeFrame: 4 hour postoperatively
measure: opioid use
timeFrame: 8 hour postoperatively
measure: opioid use
timeFrame: 12 hour postoperatively
measure: opioid use
timeFrame: 48 hour postoperatively
measure: opioid use
timeFrame: 72 hour postoperatively
measure: intraoperative fentanyl use
timeFrame: during the surgical procedure
Secondary outcomes:
measure: pain control
timeFrame: 4 hour postoperatively
measure: pain control
timeFrame: 8 hour postoperatively
measure: pain control
timeFrame: 12 hour postoperatively
measure: pain control
timeFrame: 24 hour postoperatively
measure: pain control
timeFrame: 48 hour postoperatively
measure: pain control
timeFrame: 72 hour postoperatively
measure: nausea
timeFrame: within 72 hour postoperatively
measure: Vomiting
timeFrame: within 72 hour postoperatively
measure: Dizziness
timeFrame: within 72 hour postoperatively
measure: Drowsiness
timeFrame: within 72 hour postoperatively
measure: pain interfering in general activity
timeFrame: within 72 hours postoperatively
measure: pain interfering in mood
timeFrame: within 72 hours postoperatively
measure: pain interfering in normal work
timeFrame: within 72 hours postoperatively
measure: pain interfering in relations with other people
timeFrame: within 72 hours postoperatively
measure: pain interfering in sleep
timeFrame: within 72 hours postoperatively
measure: pain interfering in enjoyment in life
timeFrame: within 72 hours postoperatively
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Chi Viet, DDS MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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