Pain, Postoperative, Narcotic Use
Conditions
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.
Interventions
DRUGMelatonin 10 MG
3 melatonin 10mg capsules will be given to the treatment arm
DRUGLactose pill
3 lactose pills will be provided to the control arm
Sponsors
Montefiore Medical Center
Quest Diagnostics-Nichols Insitute
Eurofins Viracor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The surgeon and the patient will be masked, the research coordinator will not be masked.
Intervention model description
A randomization list using a variable block size will be prepared by the study biostatistician. The lists of treatment assignments (1:1 ratio) will be kept on file.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative narcotic consumption | From the time of intervention to the completion of the surveys, approximately 2-4 weeks total | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations | Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total | 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. |
| Inflammatory markers - CRP concentrations | Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total | 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. |
| Preoperative Anxiety | On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment | 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. |
| Preoperative Sleep Quality | On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment | 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). |
| Post operative pain | The morning of the first 3 postoperative days (approximately 72 hours postoperatively) and during the postoperative appointment on POD 5, approximately 2-4 weeks. | 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. |
| Heart Rate | During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total | 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. |
| Mean Arterial Pressure (MAP) | During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Baker, DMD
Montefiore Medical Center
Outcome results
None listed