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Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

NCT04586504 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-08-06

Study results available
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Summary

Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:

Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.

Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.

Conditions

  • Procedural Anxiety

Interventions

DRUG

Intranasal midazolam

5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.

Sponsors & Collaborators

  • Emergency Medicine Foundation

    collaborator OTHER

  • Mailman School of Public Health

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Principal Investigators

  • Daniel S. Tsze, MD, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2024-05-14
Completion
2024-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04586504 on ClinicalTrials.gov