CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Midazolam +2 moredrug
Likely dose
Midazolam 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02314546
NCT02314546Phase 4Completed

Intranasal Midazolam in Children as a Pre-Operative Sedative

Bassett Healthcare·interventional·Posted Dec 11, 2014·Updated Jul 23, 2015

In Brief

A Phase 4 clinical trial evaluating Midazolam, xylocaine, and 1 other intervention for Sedation, Conscious. Completed, enrolled 15 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2014
Enrollment StartDec 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.6 years ago

Interventions

Midazolamdrug

Study participants will be randomly assigned to one of three treatment groups: * Group 1 - Placebo - Control patients will receive intranasal saline. * Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam. * Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.

xylocainedrug

Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.

saline placebodrug

Placebo - Control patients will receive intranasal saline.