By InvitationPhase 4

Pediatric Delirium

United States60 participantsStarted 2021-04-27

Plain-language summary

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

Who can participate

Age range3 Months – 9 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time to onset of pediatric delirium

Timeframe: Zero minutes to 48 hours

Time to offset of pediatric delirium

Timeframe: Zero minutes to 48 hours

Duration of pediatric delirium

Timeframe: Zero minutes to 48 hours

Trial details

NCT IDNCT04669457

SponsorUniversity of Massachusetts, Worcester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-05

View on ClinicalTrials.gov More Pediatric Delirium trials