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

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

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.

Inclusion Criteria:

• Children 7 through 12 years of age who require a painful orthopedic procedure in the pediatric orthopedic outpatient clinic or emergency department
• American Society of Anesthesiologists physical status class I or II
• The participant and parent or legal guardian understand the purpose of the study, the parent or legal guardian provides written informed consent, and the child provides assent

Exclusion Criteria:

• History of allergy to dexmedetomidine or chloral hydrate
• History of cardiovascular disease, including bradycardia or hypotension, or severe respiratory disease
• Current sedative use or receipt of another sedative within the previous 24 hours
• Inability to receive intranasal administration, including nasal obstruction or severe rhinitis
• Investigator determination that participation is inappropriate