Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children

Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial

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).

Inclusion Criteria:

• Pediatric patients who need procedural sedation (Age < 7 years)
• ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria:

• 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