Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
- Conditions
- Pain, PostoperativeNarcotic Use
- Interventions
- Registration Number
- NCT04791943
- Lead Sponsor
- Montefiore Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Treatment - Melatonin Melatonin 10 MG Premedication for three nights with 10mg melatonin Control Treatment - Lactose Lactose pill Premedication for three nights with lactose capsules
- Primary Outcome Measures
Name Time Method Postoperative narcotic consumption 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. 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
Name Time Method Inflammatory markers Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window). The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.
Preoperative Anxiety 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. 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 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. 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 Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later. The heart rate will be measured at the consultation and surgery appointment for comparison between groups.
Blood Pressure MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later. The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.
Trial Locations
- Locations (1)
Montefiore Medical Center Department of Dentistry
🇺🇸Bronx, New York, United States