Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2025-10-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative Narcotic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomization list using a variable block size will be prepared by the study biostatistician. The lists of treatment assignments (1:1 ratio) will be kept on file.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

The surgeon and the patient will be masked, the research coordinator will not be masked.

Study Groups

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Experimental Treatment - Melatonin

Premedication for three nights with 10mg melatonin

Group Type EXPERIMENTAL

Melatonin 10 MG

Intervention Type DRUG

3 melatonin 10mg capsules will be given to the treatment arm

Control Treatment - Lactose

Premedication for three nights with lactose capsules

Group Type PLACEBO_COMPARATOR

Lactose pill

Intervention Type DRUG

3 lactose pills will be provided to the control arm

Interventions

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Melatonin 10 MG

3 melatonin 10mg capsules will be given to the treatment arm

Intervention Type DRUG

Lactose pill

3 lactose pills will be provided to the control arm

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes