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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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).

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.