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

Sedation Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04820205
Study type Interventional
Source Seoul National University Hospital
Contact Jin-Tae Kim, MD, PhD
Phone 82-2-2072-3664
Email jintae73@gmail.com
Status Recruiting
Phase N/A
Start date September 3, 2021
Completion date December 31, 2025
View Details
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