Evaluating Stress Response and Anxiety Score in Paediatric Patients Sedated With Intranasal Dexmedetomidine
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
- Evaluating anxiety score
研究概览
简要总结
To date, there have been no studies done relating serum cortisol levels and intranasal dexmedetomidine sedation. However, there was a behavioral study done on pediatric patients confirming reduction serum cortisol levels with perioperative dialogue intervention.There have been a number of studies done on adult patients indicating that dexmedetomidine was indeed capable of reducing level of anxiety with evidence of lower serum cortisol levels. Hence, we postulated that intranasal dexmedetomidine administration in pediatric patients will lower the serum cortisol levels but we need to evaluate the extent of reduction.
详细描述
Justification of study
With increase in number of pediatric patients undergoing surgery, efforts need to be placed on improving quality of perioperative care and patient comfort Intranasal administration of sedative agents will be far more comfortable and create a better environment for patients as most children have a fear of needles and may resist intravenous drug administration Intranasal administration is also a far simpler and less time-consuming technique with good bioavailability of administered drugs Reduction in postoperative analgesia requirement will result in early return to daily life activities, early discharge and overall reduced length of stay and hospital costs
Pre and intraoperative
All perioperative data will be collected by an investigator who is blinded to the patient's allocation. Once the caregiver has agreed and consented to participate in this study, upon admission (1 day prior to scheduled surgery) a baseline serum cortisol level will be taken concurrent with IV line setting and blood investigations. The fasting time for all patients will be at least 6 hours prior to surgery with clear fluids being allowed up to 2 hours prior to surgery.
On the day of surgery, the patient and caregiver will be called upon 1 hour prior to operating time and baseline hemodynamic parameters will be recorded (blood pressure, heart rate and pulse oximetry SpO2). Baseline Modified Yale Preoperative Anxiety Scale (m-YPAS) will be used as an assessment tool for measuring level of preoperative anxiety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded study
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients age 1-12 years old
- •Weight of patient between 10 - 60 kgs
- •American Society of Anesthesiologist (ASA) I or II
- •Scheduled for elective and emergency surgeries
- •Caregivers able to understand and provide informed consent
排除标准
- •Allergy to study drugs (dexmedetomidine, morphine, paracetamol etc.)
- •Special need Children (Cerebral palsy, down syndrome, ADHD, ASD)
- •Serious cardiac/respiratory diseases.
- •Children with neuromuscular disorders or neurological diseases (epilepsy etc)
- •Children with Metabolic disorders
- •Difficult airway cases
- •Children on any kind of steroid therapy / HPA diseases
研究组 & 干预措施
Dexmedetomidine
Intranasal dexmedetomidine 1mcg/kg
干预措施: Dexmedetomidine (Drug)
Placebo
Intranasal normal saline equivalent to (1mcg/kg dose of dexmedetomidine)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluating anxiety score
时间窗: Baseline:(before giving study drugs) and 1 to half an hour after drugs given
To compare mean anxiety score using modified Yale Preoperative Anxiety Scales (m-YPAS)
Evaluating stress response
时间窗: Baseline: (before giving study drugs) and 1 to half an hour after drugs given
Evaluating stress response by measuring serum cortisol level (nmol/L)
次要结局
- Safety profile of Intranasal Dexmedetomidine in paediatric patients(Baseline and 10 minutes interval after study drugs given)
研究者
Huda Zainal Abidin
Lecturer and Anaesthetist
Universiti Sains Malaysia