Effect of Oral Melatonin Versus Oral Midazolam as a Premedication in Children Undergoing Tonsillectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 195
- 主要终点
- Incidence of preoperative anxiety with oral melatonin vs oral midazolam as a premedication in Children Undergoing Tonsillectomy.
研究概览
简要总结
Used as a premedication to decrease anxiety (Caumo et al., 2007). Midazolam, though has several drawbacks (McCann and Kain, 2001). Hence, an alternative premedication to midazolam will definitely have a widespread appeal.
Melatonin is a hormone secreted by the pineal gland. Melatonin is different from benzodiazepines and their derivatives in that it exerts a promoting effect on sleep by amplifying day/night differences in alertness and sleep quality and displaying a modest sleep-inducing effect, quite mild as compared to that seen with benzodiazepines (Ahmad et al., 2007). Melatonin has also been reported to cause preoperative anxiolysis and an increase in levels of sedation without impairing orientation (Naguib and Samarkandi, 2000). Hence, the aim of this study is to compare the effect of oral melatonin and oral midazolam on preoperative anxiety.
Emergence delirium (ED) was first described in the literature in the early 1960s. Although often used interchangeably with emergence agitation, it is defined as a temporary dissociated state of consciousness after discontinuation of anesthesia. The characteristics that make up ED include irritability, inconsolable crying, distress and inability to cooperate (Reduque and Verghese, 2013).
Midazolam is the most prescribed oral premedication in the preoperative setting. Its benefits include preoperative anxiolysis, amnesia, relatively rapid onset and short duration of action. Although most children have anxiolysis with midazolam, up to 29% may display a paradoxical agitation response (Shin et al., 2013).
Oral melatonin doses up to 0.4 mg/kg (maximum 20 mg) are effective in reducing ED in children (age 3-7 years) (Kain et al., 2009).
AIM OF THE WORK The study aims to compare the effects of oral melatonin and oral midazolam on preoperative anxiety as a premedication in children undergoing tonsillectomy.
详细描述
Preoperative anxiety is a common and significant concern in pediatric patients undergoing surgery. Anxiety is defined as a feeling of apprehension, fear, or uneasiness about an anticipated event, and in the surgical setting, it arises primarily from the fear of separation from parents, unfamiliar environments, painful stimuli, and the unknown nature of the procedure itself (Kain et al., 2006). Studies estimate that up to 60-70% of children experience substantial preoperative anxiety, with younger children, those with shy temperaments, and those undergoing repeated surgeries being at higher risk (Chow et al., 2016).
Causes and Contributing Factors Several factors contribute to heightened anxiety in children before surgery. These include developmental stage, previous hospitalizations, parental anxiety levels, lack of adequate preparation or information, and the presence of unfamiliar medical personnel (Fortier et al., 2010). Children aged between 1 and 5 years are especially vulnerable due to their limited coping mechanisms and fear of separation. A child's temperament, such as shyness or behavioral inhibition, also influences anxiety levels (Davidson et al., 2006).
Clinical Implications of Preoperative Anxiety Unmanaged preoperative anxiety has both immediate and long-term consequences. It can lead to increased distress during induction of anesthesia, higher requirements for anesthetic agents, postoperative pain, emergence delirium, and delayed recovery (Kain et al., 2004). Moreover, there is a correlation between preoperative anxiety and the development of postoperative maladaptive behaviors such as nightmares, bedwetting, aggression, and eating disturbances (Yuki and Daaboul, 2011) Assessment of Preoperative Anxiety Quantifying anxiety in children is essential for guiding intervention. Several validated tools are available, including the Modified Yale Preoperative Anxiety Scale (m-YPAS), which evaluates behaviors like activity level, vocalization, emotional expressivity, and use of parents. This scale is reliable in assessing anxiety levels during the preoperative period (Ramkisson, 2019).
Management Strategies Preoperative anxiety in children is a multifaceted problem that significantly affects surgical outcomes. Early identification and appropriate interventions, both behavioral and pharmacological, can reduce anxiety levels, improve compliance, and contribute to better perioperative experiences (Matthias and Samarasekera, 2012).
Management of preoperative anxiety in children includes both pharmacological and non-pharmacological methods. Non-drug approaches include parental presence during induction, behavioral interventions (e.g., distraction, play therapy, video games), and preoperative education. Pharmacological agents such as midazolam and melatonin are also widely used for anxiolysis. A multimodal approach is often the most effective (Agbayani et al., 2020).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL children with ASA class I and class II
排除标准
- •chest infection
- •Abnormal mental milestones.
- •Children with any organ dysfunction.
- •Allergies to any of the drugs used.
- •Children with Obstructive sleep apnea.
研究组 & 干预措施
Melatonin group (Group M)
All patients will be subjected to a thorough medical history, physical examination, routine preoperative investigations will be done to all children including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and partial thromboplastin time). Age, weight, and sex will be recorded.
One hour before sedation, children will be transported to an isolated recovery room near the operation room. Parental presence will be allowed throughout sedation and post sedation period. Patients will be randomly assigned to three groups first group(M group) will receive 0.3 mg per kg oral melatonin in 10 ml Dextrose 10% 45 min before surgery )Maximum dose 10mg). Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.
干预措施: Melatonin group (Drug)
Midazolam group (Group D)
All patients will be subjected to a thorough medical history, physical examination, routine preoperative investigations will be done to all children including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and partial thromboplastin time). Age, weight, and sex will be recorded. One hour before sedation, children will be transported to an isolated recovery room near the operation room. Parental presence will be allowed throughout sedation and post sedation period. Patients will be randomly assigned to three groups first group(M group) will receive 0.3 mg per kg oral midazolam in 10 ml Dextrose 10% 45 min before surgery )Maximum dose 10mg). Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.
干预措施: Midazolam group (Drug)
placebo group (Group C)
All patients will be subjected to a thorough medical history, physical examination, routine preoperative investigations will be done to all children including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and partial thromboplastin time). Age, weight, and sex will be recorded. One hour before sedation, children will be transported to an isolated recovery room near the operation room. Parental presence will be allowed throughout sedation and post sedation period. Patients will will receive 10 ml pure oral Dextrose 10% 45 min before surgery. Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.
干预措施: Control group (Drug)
结局指标
主要结局
Incidence of preoperative anxiety with oral melatonin vs oral midazolam as a premedication in Children Undergoing Tonsillectomy.
时间窗: 30 minutes after giving the drug
Assessment of sedation 30 min after the drug administration using Ramsay sedation scale.
次要结局
- 1. Effect of both drugs in reducing incidence of post operative emergence delerium(24 hours afer the procedure)
研究者
Wael Sayed El Gharabawy
assisstant professor of anesthesia, intensive care, and pain management
Ain Shams University
