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Preventing Delirium in Children Undergoing Surgery

This study is looking at ways to prevent pediatric delirium (a state of confusion and disorientation after surgery) in children aged 3 months to 9 years who are having a common ear surgery called a myringotomy. Researchers are comparing two different medications given before surgery: intra-nasal Dexmedetomidine and oral Midazolam. The goal is to see which medication is better at reducing how often children experience delirium, how long it lasts, and when it starts and stops. To join, your child must be between 3 months and 9 years old and scheduled for a myringotomy, with a healthy medical status (ASA classification I-II). The study's status is currently unclear, but it plans to enroll 60 children.

Study design
This is an interventional study where 60 participants will be randomly assigned to one of two groups to receive either intra-nasal Dexmedetomidine or oral Midazolam before surgery.
What's involved
Your child will receive one of the study medications before surgery and their behavior will be observed for up to 48 hours afterward.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 48 hours after surgery to assess for pediatric delirium.

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NCT04669457

Pediatric Delirium

Enrolling by Invitation
PHASE4Ages 3–9InterventionalPrevention
University of Massachusetts, Worcester
~60 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Intra-nasal DexmedetomidineOral Midazolam

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to onset of pediatric delirium
Measured over Zero minutes to 48 hours
+2 more outcomes measured

Conditions

Pediatric Delirium

Explore related trials

Pediatric Delirium

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • R. Ian Richmond, MD · PRINCIPAL_INVESTIGATOR · University of Massachusetts, Worcester

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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.

What this trial measures

  • Time to onset of pediatric deliriumZero minutes to 48 hours

    Time from when the patient is woken from anesthesia to the onset of delirium.

  • Time to offset of pediatric deliriumZero minutes to 48 hours

    Time from onset of delirium to the offset of delirium.

  • Duration of pediatric deliriumZero minutes to 48 hours

    Total time patient experiences delirium