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

N/ANot Yet RecruitingNCT07768566

Seoul National University Childrens Hospital44 enrolled

Overview

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.

Children may have difficulty cooperating during painful orthopedic procedures because of pain, fear, and environmental stress. Oral chloral hydrate has been widely used for pediatric sedation but may cause vomiting, prolonged recovery, and respiratory depression. Dexmedetomidine is an alpha-2 adrenergic agonist with sedative and analgesic effects, minimal respiratory depression, and a noninvasive intranasal route of administration. Evidence comparing these drugs specifically during painful pediatric orthopedic manipulation is limited. Eligible participants will be randomized in a double-blind, double-dummy design. The control group will receive oral chloral hydrate 50 mg/kg and intranasal saline. The experimental group will receive oral saline and intranasal dexmedetomidine 3 micrograms/kg delivered with a mucosal atomizer device. Both preparations will be administered 30 minutes before the planned procedure. Standard local anesthesia will be used in both groups according to the procedure, including a hematoma block for fracture reduction and lidocaine infiltration for pin removal. Heart rate, respiratory rate, and oxygen saturation will be monitored before and after dosing and during sedation and recovery. PSSS will be assessed every 5 minutes from dosing through the end of the procedure. If sedation remains insufficient and the procedure cannot be performed 30 minutes after dosing, rescue sedation may be given at one-half of the initial dose using the same administration route. Participants will be observed until full recovery, which is expected to require approximately 3 to 4 hours from study-drug administration.

Study Type

INTERVENTIONAL

Interventions

DexmedetomidineDRUG

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

Chloral HydrateDRUG

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

Intranasal Saline PlaceboDRUG

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

Oral Saline PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Procedural Sedation Success Based on the Pediatric Sedation State Scale

Number and percentage of participants with a PSSS score maintained from 1 through 4 throughout the procedure. The highest PSSS score observed from procedure start through procedure end represents the lowest level of sedation. PSSS ranges from 0 to 5; lower scores indicate deeper sedation. A score of 0 indicates a serious oversedation event requiring respiratory support, and a score of 5 indicates insufficient sedation that interferes with the procedure. Any score of 0 or 5 is classified as sedation failure.

Time frame: From procedure start through procedure completion, assessed every 5 minutes within the approximately 3 to 4-hour study participation period

Secondary Outcomes

Time to Sedation

Elapsed time from the start of study-drug administration until the first PSSS score of 1, 2, 3, or 4.

Time frame: From study-drug administration until sedation is reached, expected within 30 minutes after dosing

Recovery Time

Elapsed time from attainment of sedation (PSSS 1 to 3) until the PSSS returns to 4 or 5.

Time frame: From attainment of sedation through recovery, within the approximately 3 to 4-hour study participation period

Sedation Success Without Movement

Number and percentage of participants with a PSSS score maintained from 1 through 3 throughout the procedure, indicating successful sedation without movement.

Time frame: From procedure start through procedure completion, assessed every 5 minutes

Need for Rescue Sedation

Number and percentage of participants requiring rescue sedation because the procedure cannot be performed 30 minutes after dosing due to insufficient sedation. Rescue sedation uses one-half of the initial dose through the same administration route.

Time frame: From 30 minutes after initial dosing through procedure completion

Vital-Sign Safety Events

Number and percentage of participants with any prespecified vital-sign safety event: heart rate decrease of at least 30% from baseline, apnea lasting at least 20 seconds, oxygen saturation below 95%, or a decrease in oxygen saturation of at least 10% from baseline lasting more than 10 seconds.

Time frame: From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period

Other Adverse Events

Number and percentage of participants with nausea or vomiting, allergic reaction, or other adverse events observed after study-drug administration.

Time frame: From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period

Participant Satisfaction

Participant-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.

Time frame: After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period

Parent Satisfaction

Parent-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.

Time frame: After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period

Proceduralist Satisfaction

Proceduralist-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.

Time frame: After procedure completion, within the approximately 3 to 4-hour study participation period