Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

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.
Brief Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Completion Date
Completion Date Type
Actual
Conditions
Pain, Postoperative
Narcotic Use
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
* 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
Inclusion Criteria
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

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
35 Years
Minimum Age
18 Years
NCT Id
NCT04791943
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12127
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Postoperative narcotic consumption
Outcome Time Frame
From the time of intervention to the completion of the surveys, approximately 2-4 weeks total
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Outcome Measure
Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations
Outcome Description
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.
Outcome Time Frame
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Outcome Measure
Inflammatory markers - CRP concentrations
Outcome Description
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.
Outcome Time Frame
On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Outcome Measure
Preoperative Anxiety
Outcome Description
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).
Outcome Time Frame
On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Outcome Measure
Preoperative Sleep Quality
Outcome Description
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.
Outcome 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.
Outcome Measure
Post operative pain
Outcome Description
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.
Outcome Time Frame
During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Outcome Measure
Heart Rate
Outcome Description
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.
Outcome Time Frame
During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Outcome Measure
Mean Arterial Pressure (MAP)
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
35
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jason Baker
Investigator Email
jabaker@montefiore.org
Investigator Sponsor Organization
Montefiore
Study Department
Dentistry
Study Division
Please Specify
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
PAIN, POSTOPERATIVE
POSTOPERATIVE COMPLICATIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
MELATONIN
LACTOSE
TRYPTAMINES
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS
HORMONES
HORMONES, HORMONE SUBSTITUTES, AND HORMONE ANTAGONISTS
DISACCHARIDES
OLIGOSACCHARIDES
POLYSACCHARIDES
CARBOHYDRATES
SUGARS