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Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

NCT04822064 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-24

No results posted yet for this study

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 success rate of rescue sedation after failed sedation (PSSS=4,5) with chloral hydrate (50mg/kg) The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of rescue 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 after failed sedation attempt with oral chloral hydrate. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).

Conditions

  • Sedation

Interventions

DRUG

Intranasal dexmedetomidine and ketamine

Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)

DRUG

Oral chloral hydrate

Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822064 on ClinicalTrials.gov