CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 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/NCT02356705
NCT02356705Phase 4Completed

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Jennifer Victory, RN, CCRC·interventional·Posted Feb 5, 2015·Updated Mar 16, 2022

In Brief

A Phase 4 clinical trial evaluating Midazolam, xylocaine, and 1 other intervention for Sedation. Completed, enrolled 42 participants across 1 site.

Detailed 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

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 5, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.4 years ago

Interventions

Midazolamdrug

midazolam 0.2 mg/kg given intranasally

xylocainedrug

intransal xylocaine given in conjunction with intranasal midazolam

saline placebodrug

intranasal saline given as placebo