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Search / Trial NCT04791943

Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Launched by MONTEFIORE MEDICAL CENTER · Mar 7, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether taking melatonin for three nights before having your wisdom teeth removed can help reduce pain and the need for pain medication after the surgery. Participants will either take melatonin or a placebo (a sugar pill with no active ingredients) before the procedure. Researchers will evaluate how anxious patients are before surgery, how well they sleep, and how much pain medication they need afterward, along with assessing their pain levels and some blood tests.

To join the study, you need to be between 18 and 35 years old and have 3 to 4 impacted wisdom teeth that require surgical removal under IV sedation. You should be able to speak English or Spanish and give your consent to participate. However, if you have certain health issues, like allergies to melatonin or pain medications, or if you have a history of substance abuse or sleep disorders, you may not be eligible. If you choose to participate, you'll be contributing to important research that could help improve recovery experiences for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
  • Ages 18-35
  • ASA Class I or II
  • English or Spanish speaking patients
  • Capacity to sign informed consent
  • Exclusion Criteria:
  • Allergies to melatonin, opioids, or other 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

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Jason Baker, DMD

Principal Investigator

Montefiore Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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