Status:
UNKNOWN
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
Lead Sponsor:
Seoul National University Hospital
Conditions:
Sedation
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Pediatric patients who need procedural sedation (Age \< 7 years)
- ASA (American Society of Anesthesiologists) physical status 1-3
- Failed to induce sedation with oral chloral hydrate 50mg/kg
Exclusion
- ASA (American Society of Anesthesiologists) physical status 4-5
- History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
- Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
- Cannot administrate oral medication (e.g. Swallowing difficulty)
- Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
- Unstable vital signs, Unstable arrhythmia
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04822064
Start Date
September 22 2022
End Date
December 31 2025
Last Update
November 24 2023
Active Locations (1)
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1
Jin-Tae Kim
Seoul, South Korea