CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
Intranasal midazolamdrug
Likely dose
Intranasal midazolam 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04586504
NCT04586504Phase 2Completed
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Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

Columbia University·interventional·Posted Oct 14, 2020·Updated Aug 6, 2025

In Brief

A Phase 2 clinical trial evaluating Intranasal midazolam for Procedural Anxiety. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProcedural Anxiety
CountriesUnited States
CollaboratorsEmergency Medicine Foundation, Mailman School of Public Health

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartSep 8, 2021
Primary CompletionMay 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.7 years ago

Interventions

Intranasal midazolamdrug

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