The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Total analgesic consumption
研究概览
简要总结
Orthognathic surgery is a procedure performed to correct dentofacial deformities. It involves osteotomy at the facial skeleton. Considerable pain is expected in the early recovery period.
Melatonin is a hormone that is produced naturally by the body. Synthetic Melatonin is available over the counter for the management of sleeping disorder and jetlag. Clinically, Melatonin can also be used to reduce pain and analgesic consumption in patients undergoing surgery.
Dexamethasone is a type of steroid. It can suppress the inflammatory response. It is an anti-inflammatory, anti-allergic drug. It is commonly used in head and neck and oral surgery for its anti-inflammatory effect to reduce swelling.
This study aims evaluate the efficacy of oral melatonin in the pain reduction following orthognathic surgery.
This is a double-blinded randomized controlled trial. We will recruit 87 patients who are scheduled for double-jaw orthognathic surgery to participate in this three-year study. The study lasts for 2 weeks. Participant will be randomly allocated by computer to one of the three groups. (1) Group D will receive dexamethasone only; (2) Group M will receive melatonin only; and (3) Group DM both melatonin and dexamethasone.
Postoperative pain level and perioperative plasma levels of inflammatory markers and anti-oxidizing enzymes will be recorded and compared among the study groups.
详细描述
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is endogenously produced and secreted by the pineal gland in the brain following a circadian rhythm, with a plasma concentration highest at night and lowest during the day.
The normal physiological roles of melatonin in the human body are to regulate diurnal rhythm, sleep, mood, immunity, reproduction, intestinal motility, and metabolism. Oral supplemental melatonin has been used in the management of jetlag and other sleep disorders. Recently, melatonin's analgesic, antioxidative, and neuroprotective properties have been highlighted in a number of animal models and a few human trials, although the exact cellular mechanism is still not yet clearly established. In surgical human trials, some conflicting data have been presented regarding the analgesic properties of exogenous melatonin supplement. Whilst the large proportion of studies showed that perioperative administration of melatonin yielded significantly positive effects in the reduction of postsurgical pain, and the reduction of overall morphine consumption, others demonstrated the opposite with no significant effects in pain experience. The reason for this could be related to the dosage, route of administration, and/or time of administration. To date, there is still no consensus on a standardized dosing regimen for melatonin. In non-surgical trials, melatonin has shown promising benefits in many degenerative diseases and conditions related to chronic inflammation and oxidative stress. Amongst many, the reported positive effects of melatonin ranged from the reduction of radiation dermatitis, control of signs and symptoms of ulcerative colitis, management of chronic retinopathy, and reduction of lung oxidative stress in chronic obstructive pulmonary disease patients.
Hypothesis:
Melatonin can significantly reduce postoperative pain after orthognathic surgery. Antioxidative enzyme activity and level will be elevated and the level of inflammatory markers are reduced. Melatonin has a synergistic effect with dexamethasone.
This is a double-blinded randomized controlled trial. We will recruit 87 patients who are scheduled for double-jaw orthognathic surgery to participate in this three-year study. The study lasts for 2 weeks. Participant will be randomly allocated by computer to one of the three groups. (1) Group D will receive dexamethasone only; (2) Group M will receive melatonin only; and (3) Group DM both melatonin and dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical capsules for melatonin and placebo Clear fluid of the same volume for IV dexamethasone vs normal saline
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Class I
- •Age between 18 - 60 inclusive
排除标准
- •Pregnancy
- •Any pre-existing systemic condition
- •Previous history of orthognathic surgery
- •Adverse reaction or allergic to oral melatonin
- •Need for distraction osteogenesis
- •Patient with chronic pain
- •Patients with known psychological disorders
- •Currently taking oral steroid or anti-inflammatory medication or any analgesic
研究组 & 干预措施
Dexa_Melatonin
Oral Melatonin 10mg at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2.
IV Dexamethasone 4mg/1mL on induction and continued q12h for 4 more doses
干预措施: Melatonin (Drug)
Melatonin
Oral Melatonin 10mg at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2.
IV Normal Saline (1mL) on induction and continued q12h for 4 more doses.
干预措施: Melatonin (Drug)
Dexamethasone
Placebo capsules at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2.
IV Dexamethasone 4mg/1mL on induction and continued q12h for 4 more doses
干预措施: Dexamethasone Sodium Sulphate 4mg/1mL (Drug)
Dexa_Melatonin
Oral Melatonin 10mg at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2.
IV Dexamethasone 4mg/1mL on induction and continued q12h for 4 more doses
干预措施: Dexamethasone Sodium Sulphate 4mg/1mL (Drug)
结局指标
主要结局
Total analgesic consumption
时间窗: 14 days
Total amount of postoperative analgesic consumed
Subjective pain perception
时间窗: 14 days
Self-reported pain level by numerical rating scale
次要结局
- Plasma levels and activities of antioxidative enzymes(16 days)
- Time to first analgesic(1 day)
- Plasma levels of inflammatory markers(16 days)
- Plasma levels of hydrogen peroxide(16 days)
- Plasma levels of melatonin(16 days)