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Clinical trial

Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.

ID
Name
H00021788
Description
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Trial arms
Trial start
2021-04-27
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Intra-nasal Dexmedetomidine
Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.
Arms:
Intra-nasal Dexmedetomidine
Other names:
Precedex
Oral Midazolam
Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.
Arms:
Oral Midazolam
Other names:
Midazolam
Size
60
Primary endpoint
Time to onset of pediatric delirium
Zero minutes to 48 hours
Time to offset of pediatric delirium
Zero minutes to 48 hours
Duration of pediatric delirium
Zero minutes to 48 hours
Eligibility criteria
Inclusion Criteria: * Subjects age 3 months to 9 years * Scheduled to undergo a myringotomy * American Society of Anesthesiologists (ASA) classification of I - II. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-05-26

1 organization

2 products

1 indication

Organization
University of Massachusetts, Worcester
Product
Dexmedetomidine
Indication
Delirium
Product
Midazolam