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NCT03085563 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
NCT03085563 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 63 participants.
The verdict
NCT03085563, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
Study Summary
The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Secondarily the investigators will compare patient/family and provider satisfaction while using either intranasal midazolam or N2O for minimal sedation. The investigators hypothesize that the total length of stay for children undergoing minor procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The investigators also hypothesize that patient/family and provider satisfaction will be higher with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients will receive either intranasal midazolam or N2O for minor procedures. Following the enrollment period, data will be analyzed and the two will be compared. Total length of stay, patient/family and provider satisfaction will be studied.
Interventions
- DRUG Midazolam
- DRUG Nitrous Oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2018-11-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03085563
The ClinicalTrials.gov registry entry for NCT03085563 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT03085563 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03085563 about?
NCT03085563 is a clinical study titled "A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department". The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Seconda...
What is the current status of trial NCT03085563?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2017-05-24. Estimated completion is 2018-11-08.
What interventions are being tested in trial NCT03085563?
The interventions under investigation include: Midazolam (DRUG), Nitrous Oxide (DRUG).
Who is sponsoring clinical trial NCT03085563?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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