Gabapentin for Dental Pain
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Loma Linda University
Must not be taking: Opioids, Gabapentin
Disqualifiers: Recreational drug use, Significant disorders, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic opioid or gabapentin use, you would not be eligible to participate.
What data supports the effectiveness of the drug gabapentin for dental pain?
Gabapentin has been shown to be effective in reducing pain in various conditions, such as chronic neuropathic pain and postoperative pain, which suggests it might also help with dental pain. In studies, gabapentin has provided significant pain relief compared to a placebo, indicating its potential usefulness in managing pain.
12345Is gabapentin safe for humans?
Gabapentin is generally considered safe for humans, but it can cause side effects like drowsiness, dizziness, and fatigue. It also has potential for abuse, especially when used with other sedating drugs like opioids, which can increase the risk of accidents and overdose.
36789How is the drug gabapentin unique for treating dental pain?
Gabapentin is unique for dental pain because it is originally an antiepileptic drug that is now used for various types of pain, including neuropathic pain (pain from nerve damage) and non-neuropathic pain like cancer and perioperative pain. Its mechanism of action is not fully understood, but it does not work through the usual pathways of similar drugs, making it a novel option for pain management.
210111213Eligibility Criteria
This trial is for adults with a BMI of 18-35 who need at least one wisdom tooth removed. They should be generally healthy (ASA I or II), able to follow the study plan, and give informed consent. Excluded are those allergic to gabapentinoids, using opioids or gabapentin regularly, with a history of drug abuse, significant health issues, recent illness, oral pathology, pregnant/breastfeeding women, or unable to legally consent.Inclusion Criteria
You are in good health according to your doctor's evaluation.
Subjects must be willing and able to comply with protocol requirements.
I need to have at least one wisdom tooth removed.
+9 more
Exclusion Criteria
I do not have any mouth diseases.
I have not had a serious illness or condition in the last 14 days.
I have been using opioids or gabapentin regularly for more than 3 months.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person)
Preoperative Administration
Participants receive 600 mg of gabapentin or placebo 2 hours before the procedure
2 hours
1 visit (in-person)
Surgical Procedure
Wisdom teeth extraction performed under IV sedation with intraoperative monitoring of opioid use
1 day
1 visit (in-person)
Postoperative Monitoring
Participants' pain levels and side effects are monitored at intervals of 4, 8, 12, 24, and 72 hours post-procedure
72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a follow-up visit to turn in the MBPI form
1 week
1 visit (in-person)
Participant Groups
The study tests if taking Gabapentin (600mg) before wisdom teeth extraction reduces pain better than a placebo. It's randomized and double-blind meaning neither patients nor doctors know who gets the real medicine. Pain levels and side effects are tracked up to three days after surgery.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gabapentin groupExperimental Treatment1 Intervention
The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery.
Group II: Placebo groupPlacebo Group1 Intervention
The patient in this group will take a placebo that looks like gabapentin PO 2 hours prior to his or her surgery.
Gabapentin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neurontin for:
- Postherpetic neuralgia
- Partial-onset seizures
🇪🇺 Approved in European Union as Gabapentin for:
- Peripheral neuropathic pain
- Partial-onset seizures
🇨🇦 Approved in Canada as Gabapentin for:
- Postherpetic neuralgia
- Partial-onset seizures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loma Linda University HealthLoma Linda, CA
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Who Is Running the Clinical Trial?
Loma Linda UniversityLead Sponsor
References
Analgesic efficacy of prophylactic gabapentin and lornoxicam in preventing postendodontic pain. [2018]In dental applications, as in all other medical applications, pain needs to be prevented or at least controlled. The use of the tooth as a model for studying pain mechanisms is well established. In the current study, we aimed to evaluate and compare the analgesic effects of gabapentin and lornoxicam, respectively, vs a placebo for postendodontic treatment pain.
Gabapentin for Chronic Neuropathic Pain. [2018]Is gabapentin associated with pain relief in people with chronic neuropathic pain?
Update on gabapentin therapy of neuropathic pain. [2006]To provide current information regarding the efficacy and tolerability of the anticonvulsant gabapentin in the management of neuropathic pain.
Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study). [2021]Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. The GAP study will compare the effectiveness, cost-effectiveness and safety of gabapentin as an adjunct to standard multimodal analgesia versus placebo for the management of pain after major surgery.
Gabapentin in the treatment of neuropathic pain. [2022]This paper reviews the pharmacology and clinical effectiveness of gabapentin in the treatment of neuropathic pain. Gabapentin has antihyperalgesic and antiallodynic properties but does not have significant actions as an anti-nociceptive agent. Its mechanisms of action appear to be a complex synergy between increased GABA synthesis, non-NMDA receptor antagonism and binding to the alpha2delta subunit of voltage dependent calcium channels. The latter action inhibits the release of excitatory neurotransmitters. Clinically, several large randomized controlled trials have demonstrated its effectiveness in the treatment of a variety of neuropathic pain syndromes. Patients with neuropathic pain can expect a mean reduction in pain score of 2.05 points on an 11 point numerical rating scale compared with a reduction of 0.94 points if they had taken the placebo. Around 30% of patients can expect to achieve more than 50% pain relief and a similar number will also experience minor adverse events; the most common of which are somnolence and dizziness. In patients with neuropathic pain due to cancer, higher response rates might be observed with gabapentin when administered with opioids because of a synergistic interaction.
Prevalence of gabapentin in impaired driving cases in Washington State in 2003-2007. [2019]Gabapentin (Neurontin) is an antiepileptic drug commonly prescribed for pain treatment. In the past 15 years, indications for gabapentin have been increasing even though the complete mechanism of action is unknown. Side effects include somnolence, dizziness, ataxia, nystagmus, and fatigue. This study reviewed all cases positive for gabapentin submitted to the Washington State Toxicology Laboratory between January 2003 and December 2007. The concentrations of gabapentin in blood from impaired driving cases (n = 137) ranged from
Abuse potential of gabapentin in dentistry. [2018]Gabapentin is an anticonvulsant drug widely prescribed for various ailments, including orofacial pain. It was once thought to have no potential for abuse; however, the last decade has seen a dramatic rise in the nonmedical use of gabapentin, particularly among opioid-dependent patients. Gabapentin is sedating and interacts with other sedating medications such as opioids, which can lead to impairment and accidents and may raise the risk of overdose. Dentists must be aware of the potential for abuse of gabapentin and weigh its benefits against its risks when prescribing the drug.
Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. [2022]Gabapentin (Neurontin) is prescribed widely for conditions for which it has not been approved by regulators, including certain neuropathic pain conditions. There is limited evidence that gabapentin is safe and effective for the treatment of neuropathic pain. Published trial reports, and systematic reviews based on published trial reports, mislead patients and providers because information about gabapentin's harms has been published only partly. We confirmed that trials conducted by the drug developer have been abandoned, and we plan to conduct a restoration with support from the Restoring Invisible and Abandoned Trials Support Centre (https://restoringtrials.org/).
Administration of four different doses of gabapentin reduces awakening from breakthrough pain and adverse effects in outpatients with neuropathic pain during the initial titration. [2021]Gabapentin is a safe and well-tolerated anticonvulsant with a wide therapeutic index, and it is used for neuropathic pain. The aim of this study was to compare previous dosing methods with the administration of four different doses of gabapentin while maintaining the same maximum daily dose for the safe administration of high doses of the medication.
Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? [2019]Gabapentin (Neurontin 1 ) and pregabalin (Lyrica 2 ) are first- and second-generation α2δ ligands, respectively, and are both approved for use as adjunctive therapy in pain control. Although they do not bind to gamma-aminobutyric acid (GABA) receptors they have been successfully used to treat neuropathic pain conditions. Their mechanism of action is not yet fully understood, but research has demonstrated promising results. Despite their similarities, they have been used in combination in both clinical and research situations, and have been noted to have a synergistic effect in pain control without concern for clinically significant pharmacokinetic interactions. This combined approach can be made use of to reduce the dose of an individual agent, its side effects, and to enhance therapeutic response compared to a single agent. Pharmacokinetics, drug interactions, and adverse reaction to combinations have to be taken into consideration before combination therapy with gabapentin and pregabalin is proposed as first-line treatment in refractory pain situations and in patients with low levels of tolerance for an individual agent.
Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. [2018]Gabapentin (GBP), originally an antiepileptic drug, is more commonly used in the treatment of neuropathic pain. In recent years, GBP has been used as an adjunct or primary therapy in non-neuropathic pain, most commonly for the treatment of perioperative and cancer pain.
[Clinical response of gabapentin for glossopharyngeal neuralgia]. [2018]The analgesic effect of the antiepileptic drug gabapentin makes it useful as an alternative for neuropathic pain. Its structural resemblance to other GABAergic antiepileptic drugs does not explain its mechanism of action, which seems not to depend on the activation of GABA receptor. Glossopharyngeal neuralgia is a rare entity which presents paroxystic crisis of pain, often with unknown etiology and poor response to treatment.
Gabapentin for chronic neuropathic pain in adults. [2022]Gabapentin is commonly used to treat neuropathic pain (pain due to nerve damage). This review updates a review published in 2014, and previous reviews published in 2011, 2005 and 2000.