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NCT02356705 · ClinicalTrials.gov registry record · Phase 4
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
A Phase 4 study, sponsored by Jennifer Victory, RN, CCRC.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT02356705: Completed Phase 4 study, sponsored by Jennifer Victory, RN, CCRC.
NCT02356705 is a Phase 4 study that has completed, run by Jennifer Victory, RN, CCRC. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356705, a Phase 4 study, has completed, sponsored by Jennifer Victory, RN, CCRC.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study Summary
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
Primary Outcome
Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score)
Interventions
- DRUG Midazolam
- DRUG saline placebo
- DRUG xylocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT02356705 record still lists
NCT02356705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT02356705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02356705 about?
NCT02356705 is a clinical study titled "Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2". Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving ...
What is the current status of trial NCT02356705?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2015-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02356705?
The interventions under investigation include: Midazolam (DRUG), saline placebo (DRUG), xylocaine (DRUG).
Who is sponsoring clinical trial NCT02356705?
This trial is sponsored by Jennifer Victory, RN, CCRC, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02356705's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 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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