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

Seoul National University

Status

Completed

Conditions

Sedation

Treatments

Drug: Intranasal dexmedetomidine and ketamine

Drug: Oral chloral hydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04820205

IN DEXKET first

Details and patient eligibility

About

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).

Enrollment

136 patients

Sex

All

Ages

Under 7 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

136 participants in 2 patient groups

intranasal dexmedetomdine and kemtaine

Experimental group

Description:

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)

Treatment:

Drug: Intranasal dexmedetomidine and ketamine

oral chloral hydrate

Active Comparator group

Description:

Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)

Treatment:

Drug: Oral chloral hydrate