Status:
RECRUITING
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Quest Diagnostics-Nichols Insitute
Eurofins Viracor
Conditions:
Pain, Postoperative
Narcotic Use
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess if melatonin given for three nights before wisdom tooth surgery decreases post-operative pain and pain medication consumption. Patients will receive either melato...
Eligibility Criteria
Inclusion
- Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
- Ages 18-35
- ASA Class I or II
- English or Spanish speaking patients
- Capacity to sign informed consent
Exclusion
- Allergies to melatonin, opioids, or other OTC pain medications
- Anyone currently taking melatonin for any reason
- Cases under local anesthesia
- ASA class III or higher
- Sleep disorder (insomnia/narcolepsy)
- Current or past history of substance abuse
- Chronic pain
- Language/communication barrier
- Psychiatric disease/ Mental impairment
- Current or past use of psychotropic drugs
- Pregnancy
- Renal or hepatic impairment
- BMI \>35
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04791943
Start Date
May 12 2021
End Date
December 1 2026
Last Update
June 26 2025
Active Locations (1)
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1
Montefiore Medical Center Department of Dentistry
The Bronx, New York, United States, 10467