Comparing two methods for sedation in children after failed sedation attempts
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial
This study is testing whether a nasal spray or an oral medication works better for calming young children who didn't get enough sedation from a previous treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 7 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04822064 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intranasal dexmedetomidine and ketamine compared to oral chloral hydrate for rescue sedation in pediatric patients who did not achieve adequate sedation with chloral hydrate. The study involves a prospective, parallel-arm, single-blinded, multi-center, randomized controlled design. Pediatric patients under 7 years old who have failed sedation with chloral hydrate will be randomized to receive either the intranasal combination or the oral medication. The primary outcome is the success rate of rescue sedation within 15 minutes after administration.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 7 years old who require procedural sedation and have failed to achieve sedation with oral chloral hydrate.
Not a fit: Patients with ASA physical status 4-5 or those with contraindications to the medications used may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective sedation option for pediatric patients who do not respond to traditional methods.
How similar studies have performed: Other studies have shown promising results with similar sedation approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Jin-Tae Kim — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jin-Tae Kim, MD. PhD
- Email: jintae73@gmail.com
- Phone: 82-2-2072-3664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.