Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Study Overview
=================
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.

Official Title
-----------------
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Conditions
-----------------
Pain, Postoperative, Narcotic Use

Intervention / Treatment
-----------------
* Drug: Melatonin 10 MG
* Drug: Lactose pill


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response. | Blood draws at the consultation, surgery day, and at the 5 day post operative visit ( 2-4 week window). | 
| 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). | 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. | 
| 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. | 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. | 
| Heart Rate | The heart rate will be measured at the consultation and surgery appointment for comparison between groups. | Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later. | 
| Blood Pressure | The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups. | MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later. |