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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Chloral Hydrate; Dexmedetomidine; Ketamine

Criteria

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