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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: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT03085563 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 63 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The total length of Emergency Department (ED) stay will be defined as time from intranasal midazolam or nitrous oxide administration to time of discharge readiness, collected by the research assistants. Additional time periods measured will include: time from anxiolytic/sedative given to time of procedure completion, and total time for recovery.
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 |
What the finished NCT03085563 record still lists
NCT03085563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT03085563 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03085563's enrollment target sits among peer trials
63 1106th of 2000 higher than 891 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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