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Melatonin for Postoperative Pain

Phase 2
Recruiting
Led By Jason Baker, DMD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
Ages 18-35
Must not have
Current or past use of psychotropic drugs
BMI >35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
Awards & highlights

Summary

This trial will test if melatonin can decrease post-operative pain and pain medication consumption for patients having wisdom tooth surgery.

Who is the study for?
This trial is for healthy adults aged 18-35 needing wisdom tooth surgery under IV sedation, without allergies to melatonin or pain meds, no chronic pain or psychiatric conditions, not pregnant, and not currently using melatonin. They must be able to understand and sign the consent form.
What is being tested?
The study tests if taking melatonin for three nights before wisdom tooth removal can reduce post-surgery pain and need for painkillers. Participants will randomly receive either melatonin or a placebo pill (lactose) to compare effects on anxiety, sleep quality, post-op pain, medication use, and blood values.
What are the potential side effects?
Melatonin may cause drowsiness or sleepiness; however it's generally considered safe with minimal side effects when used short-term. The placebo should have no active side effects since it contains lactose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need 3-4 wisdom teeth removed with surgery under IV sedation.
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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used or am using medication for mental health issues.
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My BMI is over 35.
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I am allergic to melatonin, opioids, or some over-the-counter pain medications.
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I am currently taking melatonin.
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I have a sleep disorder like insomnia or narcolepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative narcotic consumption
Secondary study objectives
Blood Pressure
Heart Rate
Inflammatory markers
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Treatment - MelatoninExperimental Treatment1 Intervention
Premedication for three nights with 10mg melatonin
Group II: Control Treatment - LactosePlacebo Group1 Intervention
Premedication for three nights with lactose capsules

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
455 Previous Clinical Trials
583,007 Total Patients Enrolled
Jason Baker, DMDPrincipal InvestigatorMontefiore Medical Center

Media Library

Melatonin 10 MG Clinical Trial Eligibility Overview. Trial Name: NCT04791943 — Phase 2
Postoperative Pain Research Study Groups: Experimental Treatment - Melatonin, Control Treatment - Lactose
Postoperative Pain Clinical Trial 2023: Melatonin 10 MG Highlights & Side Effects. Trial Name: NCT04791943 — Phase 2
Melatonin 10 MG 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791943 — Phase 2
~16 spots leftby Dec 2025
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