Clinical Research Directory

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

Sponsor: Seoul National University Childrens Hospital

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.

Official title: Procedural Sedation With Intranasal Dexmedetomidine Versus Oral Chloral Hydrate for Painful Orthopedic Manipulation: A Prospective Randomized Controlled Study

Key Details

Conditions

Interventions

Locations (1)