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Tests treatment safety and results for Dental Pain and Sensation Disorder
Official title Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
ClinicalTrials.gov ID: NCT04860141
What this study is testing
What is Gabapentin 600mg?
Gabapentin 600mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dental pain and sensation disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59. Healthy volunteers may be eligible.
You may be able to join if
- people 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.
- people must be willing and able to comply with protocol requirements.
- people 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...
You likely can't join if
- 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...
- Patients with baseline pain.
- Patients with any oral pathology will be excluded.
See the full eligibility criteria
- people 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.
- people must be willing and able to comply with protocol requirements.
- people 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.