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Intranasal Dexmedetomidine vs. Oral Chloral Hydrate for Pediatric Orthopedic Procedural Sedation

NCT07768566 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-08-17

No results posted yet for this study

Summary

This prospective randomized controlled study will compare the effectiveness and safety of intranasal dexmedetomidine with oral chloral hydrate for procedural sedation in children undergoing painful orthopedic manipulation. Forty-four children 7 to 12 years of age will be assigned in a 1:1 ratio to receive either intranasal dexmedetomidine 3 micrograms/kg plus oral saline or oral chloral hydrate 50 mg/kg plus intranasal saline. Both the participants and the clinicians performing the procedure will be blinded to treatment assignment. The primary outcome is successful sedation throughout the procedure, defined as a Pediatric Sedation State Scale (PSSS) score maintained between 1 and 4. Secondary outcomes include time to sedation, recovery time, sedation without movement, need for rescue sedation, vital-sign safety events, other adverse events, and participant, parent, and clinician satisfaction.

Conditions

  • Pediatric Procedural Sedation

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine 3 micrograms/kg administered intranasally through a mucosal atomizer device 30 minutes before the planned procedure. The dose is divided between both nostrils.

DRUG

Chloral Hydrate

Chloral hydrate 50 mg/kg administered orally 30 minutes before the planned procedure.

DRUG

Intranasal Saline Placebo

An equal volume of normal saline administered intranasally 30 minutes before the planned procedure to maintain the double-dummy masking.

DRUG

Oral Saline Placebo

An equal volume of normal saline administered orally 30 minutes before the planned procedure to maintain the double-dummy masking.

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Seoul National University Childrens Hospital

    lead OTHER

Principal Investigators

  • Mi Hyun Song · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2028-12-31

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 NCT07768566 on ClinicalTrials.gov