Effectiveness and Safety of Nebulized Ketamine in Severe Pediatric Asthma: a Phase-2, Double-blind, Randomized, Placebo-controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pediatric Respiratory Assessment Measure (PRAM) score.
研究概览
简要总结
This is a double-blinded, randomised, placebo-controlled trial enrolling 60 children aged 1 to 13 years with severe asthma exacerbation. All participants will receive standard therapy. Children not responding to standard therapy will be randomised to intervention arms. Randomization will occur in a 1:1 ratio using a computer-generated Excel sequence with permuted blocks of four, stratified by age (1-5 and 6-13 years). Patients will receive either nebulized ketamine (1 mg/kg every 6 hours for 24 hours) or 0.9% normal saline placebo. Randomization codes will be maintained by the hospital pharmacy, which will prepare identical numbered packs. During working hours, the pharmacist will dispense the allocated medication; at nights and weekends, pre-prepared packs will be stored securely in the PHDU/PICU under the supervision of the nursing in-charge. Blinding will be maintained for patients, clinicians, and outcome assessors. PRAM scores will be recorded at baseline and at 20, 60, 90, and 120 minutes post-dose. The primary outcome is pediatric respiratory assessment measure (PRAM) score change. Secondary outcomes include need for NIV or intubation and HDU/PICU length of stay.
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)
盲法说明
An independent statistician will generate a computer-based allocation list with variable permuted blocks, stratified by age group (1-5 vs 6-13 years). The hospital pharmacy will prepare 60 sequentially numbered, identical medication packs (001-060) containing either ketamine or 0.9% saline according to this concealed list. Packs will be visually indistinguishable (same volume and appearance); only the pack number will appear on the label. At enrolment, the bedside team will request the next available pack in sequence. Investigators, treating clinicians, parents/guardians, outcome assessors, and statisticians will remain blinded to treatment allocation.
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 13 years.
- •Diagnosis of severe asthma exacerbation (PRAM score 8-12)
- •Prior treatment with standard first-line management (beta-2 agonist, corticosteroid, magnesium sulfate)
排除标准
- •Known allergy or adverse reaction to ketamine
- •Significant hemodynamic instability
- •Systemic hypertension >95th percentile for age
- •Cardiac arrhythmias
- •Congestive heart failure
- •Obstructive sleep apnea with AHI >5
结局指标
主要结局
Change in Pediatric Respiratory Assessment Measure (PRAM) score.
时间窗: Baseline and 20, 60, 90, and 120 minutes post-dose (over 24 hours)
Mean difference in the change in Pediatric Respiratory Assessment Measure (PRAM) score within 60 minutes of treatment between the nebulized ketamine and placebo groups. The PRAM is a validated clinical asthma severity score ranging from 0 to 12, where higher scores indicate more severe respiratory distress (a worse outcome) and a greater reduction indicates clinical improvement.
次要结局
- Proportion of participants requiring non-invasive ventilation (NIV) or mechanical ventilation(Up to 24 hours after first dose)
- Length of stay in the HDU/PICU(Through study completion, an average of 5 days)
- Change in heart rate(Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours)
- Change in respiratory rate(Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours)
- Change in oxygen saturation(Baseline and at 20, 60, 90, and 120 minutes post-dose, up to 24 hours)
研究者
Dr. Zahraa Al Lawati
Assistant Professor
Sultan Qaboos University