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Pediatric Delirium

NCT04669457 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-18

No results posted yet for this study

Summary

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

Conditions

  • Pediatric Delirium

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2027-04-05
Completion
2027-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669457 on ClinicalTrials.gov