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

Sponsor

Loma Linda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04860141

Collaborator

(none)

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Pain and Sensation Disorder Pain, Postoperative	Drug: Gabapentin 600mg Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin group The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery.	Drug: Gabapentin 600mg The patient will take gabapentin 600mg 2 hours prior to the procedure
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.	Drug: Placebo the patient will take a pill that looks like gabapentin 2 hours prior to the procedure

Arm

Intervention/Treatment

Experimental: Gabapentin group

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

Drug: Gabapentin 600mg

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

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.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

opioid use [4 hour postoperatively]
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use [8 hour postoperatively]
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use [12 hour postoperatively]
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use [48 hour postoperatively]
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use [72 hour postoperatively]
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
intraoperative fentanyl use [during the surgical procedure]
assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case.

Secondary Outcome Measures

pain control [4 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index. (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
pain control [8 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index. (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
pain control [12 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
pain control [24 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
pain control [48 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
pain control [72 hour postoperatively]
assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity)
nausea [within 72 hour postoperatively]
If the pt is having nausea any time within 72hrs. Yes or No.
Vomiting [within 72 hour postoperatively]
If the pt is having vomiting any time within 72hrs. Yes or No.
Dizziness [within 72 hour postoperatively]
If the pt is having dizziness any time within 72hrs. Yes or No.
Drowsiness [within 72 hour postoperatively]
If the pt is having drowsiness any time within 72hrs. Yes or No.
pain interfering in general activity [within 72 hours postoperatively]
0 is not interference at all, 10 is severely interfering with life.
pain interfering in mood [within 72 hours postoperatively]
pain interfering in mood; 0 is not interference at all, 10 is severely interfering with life.
pain interfering in normal work [within 72 hours postoperatively]
pain interfering in normal work; 0 is not interference at all, 10 is severely interfering with life.
pain interfering in relations with other people [within 72 hours postoperatively]
pain interfering in relations with other people; 0 is not interference at all, 10 is severely interfering with life.
pain interfering in sleep [within 72 hours postoperatively]
pain interfering in sleep; 0 is not interference at all, 10 is severely interfering with life.
pain interfering in enjoyment in life [within 72 hours postoperatively]
pain interfering in enjoyment in life; 0 is not interference at all, 10 is severely interfering with life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)