Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes %
研究概览
简要总结
In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the success rate of rescue sedation after failed sedation (PSSS=4,5) with chloral hydrate (50mg/kg) The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of rescue sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients after failed sedation attempt with oral chloral hydrate. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients who need procedural sedation (Age < 7 years)
- •ASA (American Society of Anesthesiologists) physical status 1-3
- •Failed to induce sedation with oral chloral hydrate 50mg/kg
排除标准
- •ASA (American Society of Anesthesiologists) physical status 4-5
- •History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
- •Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
- •Cannot administrate oral medication (e.g. Swallowing difficulty)
- •Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
- •Unstable vital signs, Unstable arrhythmia
研究组 & 干预措施
intranasal dexmedetomdine and kemtaine
Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)
干预措施: Intranasal dexmedetomidine and ketamine (Drug)
oral chloral hydrate
Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)
干预措施: Oral chloral hydrate (Drug)
结局指标
主要结局
Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes %
时间窗: During pediatric procedural sedation (up to 1 hour)
Success rate of adequate rescue sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %
次要结局
- HR during sedation (/min)(During pediatric procedural sedation (up to 3 hour))
- Duration of rescue sedation = Recovery time (PSSS =4,5)(During pediatric procedural sedation (up to 3 hour))
- The incidence of hemodynamic intervention: fluid management, intravenous medication %(During pediatric procedural sedation (up to 3 hour))
- Onset time of rescue sedation (PSSS =1,2,3) (min)(During pediatric procedural sedation (up to 3 hour))
- PSSS(Pediatric Sedation State Scale, 0-5)(During pediatric procedural sedation (up to 3 hour))
- The lowest SpO2 value (%)(During pediatric procedural sedation (up to 3 hour))
- The incidence of significant bradycardia (-30% from baseline) %(During pediatric procedural sedation (up to 3 hour))
- Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)(During pediatric procedural sedation (up to 3 hour))
- Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)(During pediatric procedural sedation (up to 3 hour))
- The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)(During pediatric procedural sedation (up to 3 hour))
- Respiratory rate during sedation (/min)(During pediatric procedural sedation (up to 3 hour))
- SpO2 during sedation (%)(During pediatric procedural sedation (up to 3 hour))
- The incidence of significant apnea (>20seconds) %(During pediatric procedural sedation (up to 3 hour))
- the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %(During pediatric procedural sedation (up to 3 hour))
- The incidence of respiratory intervention: Manual ventilation or Artificial airway %(During pediatric procedural sedation (up to 3 hour))
- Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)(During pediatric procedural sedation (up to 3 hour))
- Total cost of sedation (KRW)(During pediatric procedural sedation (up to 1 day))
- The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %(During pediatric procedural sedation (up to 3 hour))
- The incidence of significant hypotension (-30% from baseline) %(During pediatric procedural sedation (up to 3 hour))
- The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min %(During pediatric procedural sedation (up to 3 hour))
- The incidence of Completion of procedure(During pediatric procedural sedation (up to 3 hour))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital