Overview

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