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NCT04586504 · ClinicalTrials.gov registry record · Phase 1
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT04586504 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 101 participants.
The verdict
NCT04586504, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study 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.
Interventions
- DRUG Intranasal midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2024-05-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04586504
The ClinicalTrials.gov registry entry for NCT04586504 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intranasal midazolam is the first listed.
NCT04586504 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04586504 about?
NCT04586504 is a clinical study titled "Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children". 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 do...
What is the current status of trial NCT04586504?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2021-09-08. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT04586504?
The interventions under investigation include: Intranasal midazolam (DRUG).
Who is sponsoring clinical trial NCT04586504?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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