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ENROLLING BY INVITATION
NCT04669457
PHASE4

Pediatric Delirium

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

Summary

Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.

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

Key Details

Gender

All

Age Range

3 Months - 9 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-04-27

Completion Date

2026-04-05

Last Updated

2025-07-25

Healthy Volunteers

Yes

Interventions

DRUG

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.

DRUG

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.

Locations (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States