Clinical trial NCT04791943: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pain, Postoperative
Narcotic Use
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative narcotic consumption
timeFrame: 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 outcomes:
measure: Inflammatory markers
timeFrame: Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
measure: Preoperative Anxiety
timeFrame: 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.
measure: Post operative pain
timeFrame: 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.
measure: Heart Rate
timeFrame: Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
measure: Blood Pressure
timeFrame: MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Department of Dentistry
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jason Baker, DMD
role: PRINCIPAL_INVESTIGATOR
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