Pediatric Delirium

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT04669457
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Pediatric Delirium

Eligibility Criteria

Sex
ALL
Age
3 Months - 9 Years
Healthy Volunteers
Accepted

Interventions

  • Intra-nasal Dexmedetomidine — DRUG
    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 Midazolam — DRUG
    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.

Study Details

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

Key Dates

Start date
Apr 27, 2021
Status verified
May 2026
Primary completion
Apr 5, 2027
Completion
Apr 5, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Time to onset of pediatric delirium [ Time Frame: Zero minutes to 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-

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By research site
University of Massachusetts Medical School· Worcester, MA