Dental Pain and Sensation DisorderPhase 4NCT04860141
Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
A Phase 4 study testing Gabapentin 600mg in people with Dental Pain and Sensation Disorder and Pain, Postoperative, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain and Sensation Disorder, Pain, Postoperative
- What is being tested?
- Gabapentin 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
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.
Read the 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.
- Being tested
- Gabapentin 600mg, Placebo
- Keywords
- gabapentin, third molar extraction, postoperative pain, intraoperative pain, opioid reduction, narcotic reduction
- Medical subject headings
- Toothache, Sensation Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 600mgDrug
The patient will take gabapentin 600mg 2 hours prior to the procedure
PlaceboDrug
the patient will take a pill that looks like gabapentin 2 hours prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin group | Experimental | The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Measured: 4 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Measured: 8 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Measured: 12 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Measured: 48 hour postoperatively
opioid use
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
Measured: 72 hour postoperatively
intraoperative fentanyl use
assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case.
Measured: during the surgical procedure
Secondary outcomes (16)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 72 hour postoperatively
nausea
If the pt is having nausea any time within 72hrs. Yes or No.
Measured: within 72 hour postoperatively
Vomiting
If the pt is having vomiting any time within 72hrs. Yes or No.
Measured: within 72 hour postoperatively
Dizziness
If the pt is having dizziness any time within 72hrs. Yes or No.
Measured: within 72 hour postoperatively
Drowsiness
If the pt is having drowsiness any time within 72hrs. Yes or No.
Measured: within 72 hour postoperatively
pain interfering in general activity
0 is not interference at all, 10 is severely interfering with life.
Measured: within 72 hours postoperatively
pain interfering in mood
pain interfering in mood; 0 is not interference at all, 10 is severely interfering with life.
Measured: 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.
Measured: 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.
Measured: within 72 hours postoperatively
pain interfering in sleep
pain interfering in sleep; 0 is not interference at all, 10 is severely interfering with life.
Measured: 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.
Measured: within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start16 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Pain and Sensation DisorderStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Viet, DDS MD PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860141
- Sponsor's protocol ID
- 5200474
- Status last verified
- Feb 2026
- First submitted
- 19 Apr 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 15271709Salama 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.
PubMed 29643553Han 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.
PubMed 27281103Grover 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.
PubMed 20083871Crisologo 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.
PubMed 29748103Felder 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.
PubMed 30583095Quintero 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.
PubMed 28223849Sanders 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.
PubMed 27459955
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
- ClinicalTrials.gov ID
- NCT04860141
- Acronym / sponsor ID
- 5200474
- Keywords
- gabapentin, third molar extraction, postoperative pain, intraoperative pain, opioid reduction, narcotic reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin group | Experimental | Drug: Gabapentin 600mgThe patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery. |
| Placebo group | Placebo comparator | Drug: PlaceboThe patient in this group will take a placebo that looks like gabapentin PO 2 hours prior to his or her surgery. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin 600mgThe patient will take gabapentin 600mg 2 hours prior to the procedure | Drug | Gabapentin group |
| Placebothe patient will take a pill that looks like gabapentin 2 hours prior to the procedure | Drug | Placebo group |
Primary outcome
opioid use
Time frame: 4 hour postoperatively
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use
Time frame: 8 hour postoperatively
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use
Time frame: 12 hour postoperatively
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use
Time frame: 48 hour postoperatively
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
opioid use
Time frame: 72 hour postoperatively
assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes.
intraoperative fentanyl use
Time frame: during the surgical procedure
assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case.
16 secondary outcomes
pain control
Time frame: 4 hour postoperatively
pain control
Time frame: 8 hour postoperatively
pain control
Time frame: 12 hour postoperatively
pain control
Time frame: 24 hour postoperatively
pain control
Time frame: 48 hour postoperatively
pain control
Time frame: 72 hour postoperatively
nausea
Time frame: within 72 hour postoperatively
Vomiting
Time frame: within 72 hour postoperatively
Dizziness
Time frame: within 72 hour postoperatively
Drowsiness
Time frame: within 72 hour postoperatively
pain interfering in general activity
Time frame: within 72 hours postoperatively
pain interfering in mood
Time frame: within 72 hours postoperatively
pain interfering in normal work
Time frame: within 72 hours postoperatively
pain interfering in relations with other people
Time frame: within 72 hours postoperatively
pain interfering in sleep
Time frame: within 72 hours postoperatively
pain interfering in enjoyment in life
Time frame: within 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 15271709Turan 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.
- Background: PubMed 29643553Salama 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.
- Background: PubMed 27281103Han 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.
- Background: PubMed 20083871Grover 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.
- Background: PubMed 29748103Crisologo 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.
- Background: PubMed 30583095Felder 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.
- Background: PubMed 28223849Quintero 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.
- Background: PubMed 27459955Sanders 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Viet, DDS MD PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin 600mg in people with Dental Pain and Sensation Disorder and Pain, Postoperative, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Je Dong Ryu, DMD MD (909-558-4423, jryu@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid use (time frame: 4 hour postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860141, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.