Pediatric Delirium

NCT04669457 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: H00021788
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Delirium

Outcome Measures

Primary Outcomes (3)

• Time to onset of pediatric delirium

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

  Zero minutes to 48 hours

• Time to offset of pediatric delirium

  Time from onset of delirium to the offset of delirium.

  Zero minutes to 48 hours

• Duration of pediatric delirium

  Total time patient experiences delirium

  Zero minutes to 48 hours

Secondary Outcomes (7)

• Drug Acceptance

  10-25 minutes prior to surgery

• Parental Separation Anxiety Scale (PSAS)

  0-48 hours

• Mask Acceptance Scale

  1-10 minutes prior to surgery

• End tidal Sevoflurane value

  0-12 hours

• Rescue analgesia in PACU

  0-6 hours post surgery

Study Arms (2)

Intra-nasal Dexmedetomidine

EXPERIMENTAL

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: Intra-nasal Dexmedetomidine

Oral Midazolam

ACTIVE COMPARATOR

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.

Drug: Oral Midazolam

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.

Also known as: Precedex

Intra-nasal Dexmedetomidine

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.

Also known as: Midazolam

Oral Midazolam

Eligibility Criteria

• Age: 3 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• R. Ian Richmond, MD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Clinical Operations, Dept of Anesthesiology and Perioperative Medicine

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: April 27, 2021
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)