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Enrolling by invitationPhase 4

Pediatric Delirium

Key facts

Who runs it
University of Massachusetts, Worcester
Where
Worcester, United StatesSee the site
Trial code
Status
Enrolling by invitation
Phase
Phase 4
People taking part
60 people, planned
Started
27 Apr 2021
Expected to end
5 Apr 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Intra-nasal Dexmedetomidine
  • Oral Midazolam
Record updated
15 July 2026

Who can take part

Age
3 months to 9 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Subjects age 3 months to 9 years
  • Scheduled to undergo a myringotomy
  • American Society of Anesthesiologists (ASA) classification of I - II

Who cannot take part

  • 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

Where in United States

  • University of Massachusetts Medical SchoolWorcester, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Intra-nasal DexmedetomidineTreatment being tested

    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.

  • Oral MidazolamExisting treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
Record updated
15 July 2026