Status:
ENROLLING_BY_INVITATION
Pediatric Delirium
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Pediatric Delirium
Eligibility:
All Genders
3-9 years
Phase:
PHASE4
Brief Summary
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Detailed Description
Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before enteri...
Eligibility Criteria
Inclusion
- Subjects age 3 months to 9 years
- Scheduled to undergo a myringotomy
- American Society of Anesthesiologists (ASA) classification of I - II.
Exclusion
- Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
- Anyone age 10 years or older.
- Anyone with an ASA classification of III or higher.
- Non-English language speaker for whom short form consent is not available.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04669457
Start Date
April 27 2021
End Date
April 5 2026
Last Update
July 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655