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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I need 3-4 wisdom teeth removed with surgery under IV sedation.
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I am between 18 and 35 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative narcotic consumption
Secondary outcome measures
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
441 Previous Clinical Trials
582,136 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly take part in this research?

"This study is only admitting 60 patients that postoperative pain and are between 18-35 years old."

Answered by AI

Are young adults eligible for this kind of research?

"Individuals aged 18 to 35 fit the bill for this particular clinical trial. That said, there are 86 other studies that cater to patients under 18 and 432 trials available for seniors."

Answered by AI

How many individuals are being signed up for this clinical trial?

"That is correct, the information available on clinicaltrials.gov demonstrates that this trial is recruiting patients as we speak. This study was first advertised on May 12th 2021 and has since been updated June 3rd of this year. The research team conducting this study needs 60 more participants, which can be found at a single location."

Answered by AI

Are there any open slots in this clinical trial for new patients?

"The study, which can be found on clinicaltrials.gov, is still recruiting patients. Originally posted on May 12th 2021, with the most recent update being June 3rd 2022."

Answered by AI

Has Melatonin 10 MG undergone the FDA's regulatory process?

"Melatonin 10 MG falls into Phase 2 of medical trials. This suggests that while there is some evidence backing its safety, no clinical data exists to support Melatonin's efficacy."

Answered by AI

Is this a groundbreaking clinical trial?

"Melatonin 10 MG has undergone 34 active clinical studies since 2007, when it was first researched by Eli Lilly and Company. 20 cities across 15 countries are currently researching this drug."

Answered by AI

What are some of the primary conditions that Melatonin 10 MG is used to alleviate?

"Melatonin 10 MG is used to help wean patients off of opioids as well as treat other conditions such adrenal cortex hormone deficiency, chronic obstructive airway disease, and bronchodilation."

Answered by AI
Recent research and studies
~15 spots leftby Apr 2025