Dexmedetomidine + Midazolam for Pediatric Delirium
Trial Summary
What is the purpose of this trial?
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Research Team
R. Ian Richmond, MD
Principal Investigator
University of Massachusetts Chan Medical School
Eligibility Criteria
This trial is for children aged 3 months to 9 years who are scheduled for ear surgery (myringotomy) and are generally healthy (ASA class I-II). It's not for kids over age 9, those with serious heart defects, or non-English speakers without short form consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants receive either intra-nasal Dexmedetomidine or oral Midazolam before surgery
Surgery and Immediate Postoperative
Surgery is performed and immediate postoperative monitoring occurs, including documentation of end tidal Sevoflurane value and rescue analgesia in PACU
Follow-up
Participants are monitored for pediatric delirium and oral analgesic use, with home behavior analysis for 48 hours post-operatively
Treatment Details
Interventions
- Dexmedetomidine
- Midazolam
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor