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Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791943
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
21.4
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 and we will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 10 MG
  • Drug: Lactose pill
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will receive either melatonin or a placebo for three nights prior to surgery and the investigator will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values. The investigators would like to determine if melatonin can prevent preoperative anxiety, improve preoperative sleep, prevent excess narcotic consumption, and decrease post operative inflammation.Patients will receive either melatonin or a placebo for three nights prior to surgery and the investigator will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values. The investigators would like to determine if melatonin can prevent preoperative anxiety, improve preoperative sleep, prevent excess narcotic consumption, and decrease post operative inflammation.
Masking:
Double (Participant, Care Provider)
Masking Description:
The surgeon and the patient will be masked, the research coordinator will not be masked.
Primary Purpose:
Prevention
Official Title:
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Actual Study Start Date :
May 12, 2021
Anticipated Primary Completion Date :
Feb 23, 2023
Anticipated Study Completion Date :
Feb 23, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative narcotic consumption [We will measure this and participants will complete the above mentioned survey. From the time participants are enrolled in the study, to completion of these surveys will take about 2-4 weeks.]

    The investigators will measure the postoperative consumption of narcotic pain medication consumption. The investigators will measure this for approximately 72 hours post operatively, there are three total surveys and each survey will take about 3 minutes to complete. The surveys will be received via text message or email and link to Surveymonkey. These surveys will come in the morning approximately 1 day after surgery, 2 days after surgery, and 3 days after surgery. The surveys will ask for the participant ID and will then ask how many tablets of ibuprofen 600mg and hydrocodone-acetaminophen have been taken since surgery or the previous survey depending on if the survey is received on day 1 versus 2 and 3.

Secondary Outcome Measures

  1. Inflammatory markers [Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).]

    The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.

  2. Preoperative Anxiety [On day of surgery the patients will fill out a short survey, described above. This survey will be given on the day of surgery, 2-4 weeks after enrollment.]

    Patients will fill out a survey to estimate their anxiety levels immediately before surgery. The investigators will measure this immediately before surgery with a survey. The survey will ask a series of 4 questions about anxiety and 1 question about sleep quality. Participants will be asked to described their anxiety on a scale of approximately 1 to 5 (1 not at all, 5 extremely highly) in relation to how worried they are about the procedure and anesthetic as well as how often they think about the procedure and anesthetic. The last question about sleep asks the participants to describe their sleep quality during the three nights prior to surgery on a scale of 1 to 5 (1 most improved, 5 much worse).

  3. Post operative pain [Patients will fill out a short survey, described above. From the time participants are enrolled in the study, to completion of these surveys will take about 2-4 weeks.]

    Patients will complete a survey and describe their pain levels on a scale 0-100. The investigators will measure this for approximately 72 hours post operatively, there are four total surveys and each survey will take about 2 minutes to complete. The surveys will be received via text message or email and link to Surveymonkey. These surveys will come in the morning approximately 1 day after surgery, 2 days after surgery, 3 days after surgery and the last survey will be administered on paper at the postoperative follow up, day 5. The surveys will ask for the participant ID and will then ask the participant to describe their worst pain they have experienced since surgery or the previous survey depending on if the survey is received on day 1 versus 2, 3, and 5.

  4. Heart Rate [Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.]

    The heart rate will be measured at the consultation and surgery appointment for comparison between groups.

  5. Blood Pressure [MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.]

    The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montefiore Medical Center Department of Dentistry Bronx New York United States 10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT04791943
Other Study ID Numbers:
  • 2020-12127
First Posted:
Mar 10, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Pain, Postoperative
Melatonin

Study Results

No Results Posted as of Jun 6, 2022