Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P \< 0.05 considered statistically significant.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intranasal Lidocaine

Patient to receive 4% lidocaine intranasally prior to midazolam

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Administered intranasally prior to Midazolam administration.

Midazolam

Intervention Type DRUG

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

Intranasal 0.9% saline

Patient to receive 0.9% Saline intranasally prior to midazolam

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

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

0.9% Saline

Intervention Type DRUG

Administered intranasally prior to Midazolam administration.

Interventions

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Lidocaine

Administered intranasally prior to Midazolam administration.

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

0.9% Saline

Administered intranasally prior to Midazolam administration.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Versed

Eligibility Criteria

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Inclusion Criteria

* Ages 6-12
* Previously healthy
* Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure

Exclusion Criteria

* Moderate to severe asthma or other chronic lung disease
* Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed.
* Any child presenting with a life-threatening condition.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes