Gabapentin for Dental Pain

Overseen By Sung Han, DDS MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Loma Linda University

Must not be taking: Opioids, Gabapentin

Disqualifiers: Recreational drug use, Significant disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

98 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{3 6 7 8 9}

How 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. ^{2 10 11 12 13}

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.

Research Team

Chi Viet, DDS MD PhD

Principal Investigator

Loma Linda University

Eligibility 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.

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.

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)

Treatment Details

Interventions

• Gabapentin
• Placebo

Trial Overview 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.

Participant Groups

Group I: Gabapentin group Experimental Treatment 1 Intervention

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

Group II: Placebo group Placebo Group 1 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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Findings from Research

Gabapentin was found to be more effective than both lornoxicam and placebo in controlling pain after endodontic treatment, as indicated by significantly lower pain scores on the visual analog scale (VAS) at various time points.

Lornoxicam also effectively reduced post-treatment pain compared to placebo, but not as effectively as gabapentin, highlighting the potential of gabapentin as a superior analgesic option in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of prophylactic gabapentin and lornoxicam in preventing postendodontic pain. Işik, B., Yaman, S., Aktuna, S., et al.[2018]

Gabapentin, taken orally at doses of 1200-3600 mg per day for 4-12 weeks, can significantly reduce chronic neuropathic pain in patients with conditions like postherpetic neuralgia and painful diabetic neuropathy.

Patients using gabapentin experienced at least a 50% reduction in pain compared to placebo, with an improvement seen in 14% to 17% more patients, highlighting its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin for Chronic Neuropathic Pain. Moore, A., Derry, S., Wiffen, P.[2018]

Gabapentin has been shown to be effective in managing neuropathic pain across various conditions, with a total of 750 cases and 511 participants in controlled trials confirming its utility at doses up to 3.6 g per day.

It is generally well-tolerated with fewer significant drug-drug interactions compared to other anticonvulsants, making it a preferred option for treating neuropathic pain, especially in patients who do not respond to traditional treatments like tricyclic antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on gabapentin therapy of neuropathic pain. Guay, DR.[2006]

The GAP study is a multicentre, double-blind, randomized controlled trial designed to evaluate the effectiveness and safety of gabapentin as an adjunct to standard pain management in patients undergoing major surgery, involving patients aged 18 and over.

The primary outcome of the study is the length of hospital stay after surgery, with secondary outcomes including pain levels, opioid use, adverse events, and quality of life, providing a comprehensive assessment of gabapentin's impact on postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Baos, S., Rogers, CA., Abbadi, R., et al.[2021]

Gabapentin is effective in treating neuropathic pain, showing a mean pain score reduction of 2.05 points on an 11-point scale compared to 0.94 points for placebo, based on large randomized controlled trials.

Its mechanism involves increasing GABA synthesis and inhibiting excitatory neurotransmitter release, and while about 30% of patients may experience over 50% pain relief, minor side effects like somnolence and dizziness are common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin in the treatment of neuropathic pain. Bennett, MI., Simpson, KH.[2022]

Gabapentin, while commonly prescribed for pain and epilepsy, has been associated with impaired driving in 137 cases studied, with a mean blood concentration of 8.4 mg/L, indicating potential risks for users.

In most cases (93%), gabapentin was found alongside other drugs, and even when it was the only drug detected, it caused symptoms that could mimic central nervous system depressants, complicating the assessment of impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of gabapentin in impaired driving cases in Washington State in 2003-2007. Peterson, BL.[2019]

Gabapentin, originally considered safe with low abuse potential, has seen a significant increase in nonmedical use, especially among patients dependent on opioids.

Due to its sedative effects and interactions with other sedating medications, gabapentin can increase the risk of impairment, accidents, and overdose, highlighting the need for careful consideration by dentists when prescribing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abuse potential of gabapentin in dentistry. Weinberg, MA., Segelnick, SL., Insler, JS.[2018]

Gabapentin, commonly prescribed for neuropathic pain, lacks sufficient evidence for its safety and efficacy, as many trial results, particularly regarding its harms, have not been fully reported.

This study aims to analyze and disclose adverse events from six previously unreported trials of gabapentin, using clinical study reports and individual participant data to provide a clearer understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. Mayo-Wilson, E., Chen, X., Qureshi, R., et al.[2022]

In a study involving outpatients with various neuropathic pain syndromes, administering gabapentin in four different doses (QID) significantly reduced average daily pain scores and sleep disturbances compared to a three-times-daily dosing method (TID).

The QID dosing method also led to fewer adverse effects, although it did not significantly change the frequency, severity, or duration of breakthrough pain compared to the TID method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of four different doses of gabapentin reduces awakening from breakthrough pain and adverse effects in outpatients with neuropathic pain during the initial titration. Yang, JY., Lee, WI., Shin, WK., et al.[2021]

Gabapentin and pregabalin, both used for neuropathic pain, can be combined effectively without significant drug interactions, potentially enhancing pain control while allowing for lower doses of each medication.

This combination therapy may help reduce side effects and improve therapeutic responses, but careful consideration of pharmacokinetics and patient tolerance is necessary before recommending it as a first-line treatment for difficult pain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? Senderovich, H., Jeyapragasan, G.[2019]

Gabapentin (GBP) has shown significant benefits in reducing pain and the need for analgesics in various surgical settings, particularly in otolaryngology, orthopedic, and abdominal surgeries, although its efficacy is limited in cardiothoracic surgery.

In cancer pain management, GBP provides mild to moderate pain relief, especially in cases with a neuropathic component, making it a valuable adjunctive therapy due to its favorable side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Yan, PZ., Butler, PM., Kurowski, D., et al.[2018]

Gabapentin has been found to effectively reduce the frequency and severity of glossopharyngeal neuralgia crises in seven out of nine patients, demonstrating its potential as a treatment option for this rare and painful condition.

The drug was well-tolerated and showed no significant interactions, making it a viable long-term management option, although patients with vascular compression of the nerve had a poorer response to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical response of gabapentin for glossopharyngeal neuralgia]. García-Callejo, FJ., Velert-Vila, MM., Talamantes-Escribá, F., et al.[2018]

Gabapentin, at doses of 1200 mg or more daily, significantly improves pain relief in adults with postherpetic neuralgia and painful diabetic neuropathy, with about 32% and 38% of participants experiencing substantial pain relief, respectively, compared to 17% and 21% with placebo.

While gabapentin is effective for some patients, it is associated with a higher rate of adverse events, with 63% of participants experiencing at least one adverse event compared to 49% for placebo, indicating that while it can provide pain relief, not all patients will benefit and some may experience side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin for chronic neuropathic pain in adults. Wiffen, PJ., Derry, S., Bell, RF., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of prophylactic gabapentin and lornoxicam in preventing postendodontic pain. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Gabapentin for Chronic Neuropathic Pain. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Update on gabapentin therapy of neuropathic pain. [2006]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Gabapentin in the treatment of neuropathic pain. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prevalence of gabapentin in impaired driving cases in Washington State in 2003-2007. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Abuse potential of gabapentin in dentistry. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. [2018]

12. Spain pubmed.ncbi.nlm.nih.gov

[Clinical response of gabapentin for glossopharyngeal neuralgia]. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Gabapentin for chronic neuropathic pain in adults. [2022]