Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Mar 25, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods to help children who need sedation for medical procedures when the first method doesn't work. In Korea, a common way to sedate young children is by giving them a medicine called oral chloral hydrate. However, if this doesn't work well, the study is testing whether a combination of two other medications—intranasal dexmedetomidine and ketamine—can be more effective in helping the child relax and be comfortable during the procedure. The researchers believe that this combination will help children settle down more quickly, within about 15 minutes.

To participate in this trial, children must be under 7 years old and need sedation for a procedure but have not responded well to oral chloral hydrate. There are some criteria that could exclude a child from joining, such as severe health issues or allergies to the medications being tested. If a child is eligible, they will be randomly assigned to receive either the standard oral chloral hydrate or the new combination of intranasal dexmedetomidine and ketamine. Parents can expect to be informed about the process and any potential risks, and the study aims to improve sedation options for young patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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