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Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Primary Purpose

Pain, Postoperative, Narcotic Use

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melatonin 10 MG
Lactose pill
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montefiore Medical Center Department of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Treatment - Melatonin

Control Treatment - Lactose

Arm Description

Premedication for three nights with 10mg melatonin

Premedication for three nights with lactose capsules

Outcomes

Primary Outcome Measures

Postoperative narcotic consumption
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

Inflammatory markers
The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.
Preoperative Anxiety
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).
Post operative pain
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.
Heart Rate
The heart rate will be measured at the consultation and surgery appointment for comparison between groups.
Blood Pressure
The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.

Full Information

First Posted
March 2, 2021
Last Updated
May 11, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04791943
Brief Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Official Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Narcotic Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
The surgeon and the patient will be masked, the research coordinator will not be masked.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment - Melatonin
Arm Type
Experimental
Arm Description
Premedication for three nights with 10mg melatonin
Arm Title
Control Treatment - Lactose
Arm Type
Placebo Comparator
Arm Description
Premedication for three nights with lactose capsules
Intervention Type
Drug
Intervention Name(s)
Melatonin 10 MG
Intervention Description
3 melatonin 10mg capsules will be given to the treatment arm
Intervention Type
Drug
Intervention Name(s)
Lactose pill
Intervention Description
3 lactose pills will be provided to the control arm
Primary Outcome Measure Information:
Title
Postoperative narcotic consumption
Description
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.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.
Time Frame
Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
Title
Preoperative Anxiety
Description
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).
Time Frame
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.
Title
Post operative pain
Description
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.
Time Frame
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.
Title
Heart Rate
Description
The heart rate will be measured at the consultation and surgery appointment for comparison between groups.
Time Frame
Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
Title
Blood Pressure
Description
The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.
Time Frame
MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles K Levin, DDS
Phone
718-904-8190
Email
montefioreomfs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Baker, DMD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center Department of Dentistry
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason S Baker, DMD
Phone
718-405-8190
Email
jabaker@montefiore.org
First Name & Middle Initial & Last Name & Degree
Charles K Levin, DDS
Phone
718-405-8190
Email
clevin@montefiore.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Citations:
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URL
http://www.cdc.gov/vitalsigns/opioid-prescribing/
Description
2. Centers for Disease Control and Prevention. (2014). Opioid Painkiller Prescribing, Where You Live Makes a Difference. Atlanta, GA: Centers for Disease Control and Prevention.

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Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

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