Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

January 28, 2026 updated by: Montefiore Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center Department of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Treatment - Melatonin
Premedication for three nights with 10mg melatonin
Drug: Melatonin 10 MG
3 melatonin 10mg capsules will be given to the treatment arm
Placebo Comparator: Control Treatment - Lactose
Premedication for three nights with lactose capsules
Drug: Lactose pill
3 lactose pills will be provided to the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative narcotic consumption
Time Frame: From the time of intervention to the completion of the surveys, approximately 2-4 weeks total
Postoperative consumption of narcotic pain medication will be measured for approximately 72 hours post operatively. Three total surveys will be administered. The surveys will be sent to participants via text message or email and include a link to SurveyMonkey. These surveys will be sent in the morning approximately 1 day, 2 days, and 3 days after surgery. The surveys will query for participant identification and then ask how many tablets of ibuprofen 600mg and hydrocodone-acetaminophen have been taken since the time of surgery or the time of previous survey depending on if the survey is received on Day 1, versus Day 2, and Day 3. The number of narcotic pain medication pills consumed postoperatively will be presented as means and standard deviations by treatment arm.
From the time of intervention to the completion of the surveys, approximately 2-4 weeks total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations
Time Frame: Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Preoperative and postoperative blood draws will be taken to measure concentrations of the inflammatory biomarkers Interleukin-6 (IL-6), Interleukin-6 (IL-8), and Tumor Necrosis Factor-alpha (TNF-alpha) to estimate systemic inflammatory response. Two sets of preoperative blood draws will be obtained. The first set (preoperative) will be drawn following consent during consultation. The second set (immediate preoperative) will be drawn just prior to the operation on Day 0. Participants will return to the office on postoperative day five (POD5) to have blood drawn for the third set of blood draws (postoperative). Concentrations for each of the inflammatory cytokines (IL-6, IL-8, and TNF- alpha) will be reported in pg/mL and results at each timepoint will be summarized by study arm using basic descriptive statistics.
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Inflammatory markers - CRP concentrations
Time Frame: Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Preoperative and postoperative blood draws will be taken to measure concentrations of C-reactive protein (CRP). CRP is produced by the liver in response to pro-inflammatory cytokines released during inflammation. Two sets of preoperative blood draws will be obtained. The first set (preoperative) will be drawn following consent during consultation. The second set (immediate preoperative) will be drawn just prior to the operation on Day 0. Participants will return to the office on postoperative day five (POD5) to have blood drawn for the third set of blood draws (postoperative). CRP concentration will be reported in mg/L and results at each timepoint will be summarized by study arm using basic descriptive statistics.
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Preoperative Anxiety
Time Frame: On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Preoperative anxiety will be assessed using an Anxiolysis Questionnaire modeled on the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Participants will complete the survey to describe anxiety levels immediately before surgery. This survey consists of 4 questions which asks participants to rate each item on a scale of 1 ("Not at all") to 5 ("Extremely" or "Extremely highly") to best describe how worried they are about the procedure and anesthetic as well as how often they think about the procedure and anesthetic. Higher scores are associated with increasing levels of anxiety with a total score of >=11 considered a key anxiety threshold. Scores will be summarized and reported using basic descriptive statistics.
On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Preoperative Sleep Quality
Time Frame: On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Sleep quality over the previous three nights while taking the premedication immediately before surgery will be assessed based on a survey response. Specifically, participants will be administered a survey and asked to rate their quality of sleep during the three nights prior to surgery on a scale of 1 ("Much improved") to 5 ("Much worse") such that lower scores are associated with increased sleep quality. Sleep quality results will be presented as frequencies (percentages).
On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Post operative pain
Time Frame: The morning of the first 3 postoperative days (approximately 72 hours postoperatively) and during the postoperative appointment on POD 5, approximately 2-4 weeks.
Post operative pain will be assessed using a Visual Analog Scale (VAS). The VAS is a unidimensional tool for measuring pain intensity. Participants will be administered a total of four surveys via text message or email with a link to SurveyMonkey. These surveys will be sent approximately 1 day, 2 days, and 3 days following surgery and will take about 2 minutes to complete. The last survey will be administered on paper during postoperative follow up, on POD5. The surveys will query for participant ID and then ask participants to describe the worst pain they have experienced since the surgery or since the previous survey depending on day administered, using the VAS. Responses for the VAS can range from 0-100 wherein 0 = "No pain" and 100 = "Worst pain imaginable" such that higher scores are indicative of greater pain intensity. Cut points on the VAS include "Mild" (1-30), "Moderate" (31-70) and "Severe" (71-100). Pain scores will be summarized using basic descriptive statistics.
The morning of the first 3 postoperative days (approximately 72 hours postoperatively) and during the postoperative appointment on POD 5, approximately 2-4 weeks.
Heart Rate
Time Frame: During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Heart rate will be measured twice during the study, once at the time of consultation and a second time immediately prior to surgery. Heart rate will be recorded in beats per minute (bpm) and summarized by study arm using basic descriptive statistics.
During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Mean Arterial Pressure (MAP)
Time Frame: During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Mean arterial pressure will be measured twice during the study, once at the time of consultation and a second time immediately prior to surgery. MAP will be recorded in millimeters of mercury (mmHg) and summarized by study arm using basic descriptive statistics.
During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Quest Diagnostics-Nichols Insitute
Eurofins Viracor

Investigators

  • Principal Investigator: Jason Baker, DMD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-12127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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