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

NCT04586504

PHASE1|PHASE2INTERVENTIONAL

Columbia University

101 participants

Started 2021-09-08 · Completed 2024-05-14

Status: Completed (as of 12-23-2025)

Conditions

Procedural Anxiety

Interventions

DRUG: Intranasal midazolam

Linked Papers (from SciSciNet-V2)

Total Papers6

Background

2

Result

0

Derived

0

Unknown

4

View on ClinicalTrials.gov

Total Citations Per Year

Brief 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.

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Background Papers4

Validation of the Pediatric Sedation State Scale

Validation of the Pediatric Sedation State Scale

Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial

Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial

Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers4

Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS)

An Observation Scale for Measuring Children's Distress During Medical Procedures

Consensus-Based Recommendations for Standardizing Terminology and Reporting Adverse Events for Emergency Department Procedural Sedation and Analgesia in Children

Evaluating Clinical Effectiveness and Pharmacokinetic Profile of Atomized Intranasal Midazolam in Children Undergoing Laceration Repair