Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

2020-12127

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 melatonin or a placebo for three nights prior to surgery and we will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values.

2021-05-12

2024-04-01

2024-04-01

Recruiting

Early phase I

60

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will receive either melatonin or a placebo for three nights prior to surgery and the investigator will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values. The investigators would like to determine if melatonin can prevent preoperative anxiety, improve preoperative sleep, prevent excess narcotic consumption, and decrease post operative inflammation.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The surgeon and the patient will be masked, the research coordinator will not be masked.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-01-05