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Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

NCT02396537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-02-23

Study results available
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Summary

The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.

Conditions

Interventions

DRUG

Lidocaine

Administered intranasally prior to Midazolam administration.

DRUG

Midazolam

Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.

DRUG

0.9% Saline

Administered intranasally prior to Midazolam administration.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David Smith, MD · UAB Department of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

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Entities

Diseases

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 NCT02396537 on ClinicalTrials.gov