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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 is a Phase 4 study that has completed, run by Jennifer Victory, RN, CCRC. The registered enrollment target is 42 participants.

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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

Interventions

  • DRUG Midazolam
  • DRUG saline placebo
  • DRUG xylocaine

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2015-01
Est. Completion 2017-12
Phase Phase 4

Sponsor

Jennifer Victory, RN, CCRC

2 total trials

What the Registry Record Tells You About NCT02356705

The ClinicalTrials.gov registry entry for NCT02356705 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jennifer Victory, RN, CCRC, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.

NCT02356705 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.