Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: a Randomized Double Blinded Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change of sCortisol from baseline to one hour after drug administration
研究概览
简要总结
The purpose of this study is to determine the effect of a single dose of Lorazepam on salivary cortisol in children undergoing digestive endoscopy. To do so, the patients will be randomized in three groups. The first group receives the Lorazepam, the second group receives a placebo and the last group receives no intervention. Each patient will have three saliva samples taken at three different time point on the day of the endoscopy and will be asked to fill out questionnaires on anxiety and overall satisfaction of the procedure.
详细描述
Background: Pediatric digestive endoscopies (gastroscopy and colonoscopy) are invasive procedures. All endoscopic procedure are conducted in the operating room either under intravenous (IV) sedation or general anesthesia. More than 50% of procedures are performed using IV sedation. The current sedation protocol in the endoscopy suite is a combination of Midazolam (0.1 mg/kg) and Fentanyl (1 microgram/kg) in all children. The children undergoing colonoscopies receive and additional administration of Ketamine (0.5 mg/kg).
In a previous study performed in children 10-18 years undergoing upper and lower endoscopy, the investigators found that despite this regimen, 25% of the children expressed a significantly high level of pain during endoscopy under IV sedation.
Because general anesthesia is not available for all children, it is important to investigate strategies that could help in minimizing the discomfort and pain during the procedure.
Salivary cortisol (sCortisol) has been used in several pediatric studies to determine the level of stress in children prior to various medical procedures. In another study done at our site, the investigators have found sCortisol to be a reliable biomarker of stress for children undergoing digestive endoscopies. Furthermore, the mean baseline sCortisol levels were higher in the group that experienced procedural pain.
Lorazepam is a a rapid onset benzodiazepine that has anxiolytic and sedative properties that has been approved by Health Canada as an adjunct therapy for the relief of excessive anxiety that might be present prior to surgical interventions.
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, Investigator)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 9-18 seen in our endoscopic unit
- •Children undergoing upper, lower or combined digestive endoscopy
- •Procedure to be performed within 3 hours of inclusion in the study and drug administration
排除标准
- •Unable to read or speak English or French
- •Diagnosed with a psychiatric or neurological disorder
- •Myasthenia gravis
- •Acute narrow angle glaucoma
- •Known hypersensitivity to benzodiazepines
- •Already treated with an anxiolytic on a regular basis
- •Receiving a drug contraindicated in association with benzodiazepines
- •Receiving oral, intravenous or inhaled corticosteroids in the last two days before randomization
- •Body weight less than 20 kg
- •Pregnancy
研究组 & 干预措施
Group A
Patient will receive a single dose of either 0,5mg or 1mg of oral Lorazepam depending on their body weight.
干预措施: Lorazepam (Drug)
Group B
Patient will receive a placebo similar in color, form and size.
干预措施: Placebo (Other)
结局指标
主要结局
Change of sCortisol from baseline to one hour after drug administration
时间窗: One hour after drug administration
Proportion of children with a decrease of sCortisol of at least 15 points between the group Placebo and the group Lorazepam
次要结局
- Procedural pain(during endoscopic procedure)
- Duration of endoscopic procedure(Through completion of endoscopy: an average of 2 hours after drug administration)
- Physician Satisfaction(during the endoscopic procedure)
- Children Satisfaction(Through study completion, an average of 3 hours)
- Nurse Satisfaction(during the endoscopic procedure)
- Change in sCortisol levels between pre-op and post-op(one hour after the endoscopic procedure)
- Medication needed For sedation(during the procedure)
研究者
Jantchou Prevost
MD,PhD
St. Justine's Hospital