Status:
RECRUITING
Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
Lead Sponsor:
Loma Linda University
Conditions:
Dental Pain and Sensation Disorder
Pain, Postoperative
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04860141
Start Date
June 16 2021
End Date
January 1 2026
Last Update
April 6 2025
Active Locations (1)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354