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Intranasal Midazolam in Children as a Pre-Operative Sedative

NCT02314546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-07-23

Study results available
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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.

Conditions

  • Sedation, Conscious

Interventions

DRUG

Midazolam

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.

DRUG

xylocaine

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.

DRUG

saline placebo

Placebo - Control patients will receive intranasal saline.

Sponsors & Collaborators

  • Bassett Healthcare

    lead OTHER

Principal Investigators

  • david Ullman, MD · Bassett Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314546 on ClinicalTrials.gov