Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Success rate of adequate 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 first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural 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 undergoing procedural sedation. 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
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
Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
干预措施: Intranasal dexmedetomidine and ketamine (Drug)
oral chloral hydrate
Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
干预措施: Oral chloral hydrate (Drug)
结局指标
主要结局
Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes %
时间窗: During pediatric procedural sedation (up to 1 hour)
Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %
次要结局
- Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)(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))
- The incidence of failure of adequate sedation (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))
- Total cost of sedation (KRW), optional(During pediatric procedural sedation (up to 1 day))
- Onset time of sedation (PSSS= 0,1,2,3) (min)(During pediatric procedural sedation (up to 3 hour))
- Duration of sedation = Recovery time (PSSS= 4,5) (min)(During pediatric procedural sedation (up to 3 hour))
- PSSS(Pediatric Sedation State Scale, 0-5)(During pediatric procedural sedation (up to 3 hour))
- Heart rate during sedation (/min)(During pediatric procedural sedation (up to 3 hour))
- SpO2 during sedation (%)(During pediatric procedural sedation (up to 3 hour))
- Respiratory rate during sedation (/min)(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))
- 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 apnea (>20seconds) %(During pediatric procedural sedation (up to 3 hour))
- The lowest SpO2 value (%)(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))
- The incidence of significant bradycardia (-30% from baseline) %(During pediatric procedural sedation (up to 3 hour))
- The incidence of significant hypotension (-30% from baseline) %(During pediatric procedural sedation (up to 3 hour))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital