Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative narcotic consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
The surgeon and the patient will be masked, the research coordinator will not be masked.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Treatment - Melatonin
Premedication for three nights with 10mg melatonin
干预措施: Melatonin 10 MG (Drug)
Control Treatment - Lactose
Premedication for three nights with lactose capsules
干预措施: Lactose pill (Drug)
结局指标
主要结局
Postoperative narcotic consumption
时间窗: 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.
次要结局
- 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)
- Inflammatory markers - CRP concentrations(Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total)
- Preoperative Anxiety(On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment)
- Preoperative Sleep Quality(On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment)
- 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.)
- Heart Rate(During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total)
- Mean Arterial Pressure (MAP)(During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total)