Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative; Narcotic Use

Treatments: Drug: Melatonin 10 MG; Drug: Lactose pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04791943

2020-12127

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
• Ages 18-35
• American Society of Anesthesiologists (ASA) Class I or II
• English or Spanish speaking patients
• Capacity to sign informed consent

Exclusion criteria

• Allergies to melatonin, opioids, or other Over-the-counter (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Experimental Treatment - Melatonin

Experimental group

Description:

Premedication for three nights with 10mg melatonin

Treatment:

Drug: Melatonin 10 MG

Control Treatment - Lactose

Placebo Comparator group

Description:

Premedication for three nights with lactose capsules

Treatment:

Drug: Lactose pill