A Phase 4 interventional study of Gabapentin 600mg and Placebo in Dental Pain and Sensation Disorder and Pain, Postoperative, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Loma Linda University · Phase 4, Interventional, and Prevention
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.
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:
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 98 is above the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery.
Drug: Gabapentin 600mg
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 gabapentin 600mg 2 hours prior to the procedure
the patient will take a pill that looks like gabapentin 2 hours prior to the procedure
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Time frame: 4 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Time frame: 8 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Time frame: 12 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Time frame: 48 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Time frame: 72 hour postoperatively
intraoperative fentanyl use
assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case.
Time frame: during the surgical procedure
pain control
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)
Time frame: 4 hour postoperatively
pain control
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)
Time frame: 8 hour postoperatively
pain control
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)
Time frame: 12 hour postoperatively
pain control
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)
Time frame: 24 hour postoperatively
pain control
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)
Time frame: 48 hour postoperatively
pain control
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)
Time frame: 72 hour postoperatively
nausea
If the pt is having nausea any time within 72hrs. Yes or No.
Time frame: within 72 hour postoperatively
Vomiting
If the pt is having vomiting any time within 72hrs. Yes or No.
Time frame: within 72 hour postoperatively
Dizziness
If the pt is having dizziness any time within 72hrs. Yes or No.
Time frame: within 72 hour postoperatively
Drowsiness
If the pt is having drowsiness any time within 72hrs. Yes or No.
Time frame: within 72 hour postoperatively
pain interfering in general activity
0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
pain interfering in mood
pain interfering in mood; 0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
pain interfering in normal work
pain interfering in normal work; 0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
pain interfering in relations with other people
pain interfering in relations with other people; 0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
pain interfering in sleep
pain interfering in sleep; 0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
pain interfering in enjoyment in life
pain interfering in enjoyment in life; 0 is not interference at all, 10 is severely interfering with life.
Time frame: within 72 hours postoperatively
Plan to share: No — As of right now we do not intend to share any study protocol or statistical analysis plan other than what will be described in the published documentation.
Started Jun 2021 (actual). Primary completion is estimated for Dec 2026, 66 months after the start.
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Studies of the drug tested here: Gabapentin