Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

University of Alabama at Birmingham77 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

LidocaineDRUG

Administered intranasally prior to Midazolam administration.

MidazolamDRUG

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

0.9% SalineDRUG

Administered intranasally prior to Midazolam administration.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Discomfort With Intranasal Midazolam Administration

subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying "No Hurt") and a maximum score of 10 ("Hurts Worst"). Values between include 2 ("Hurts Little Bit"), 4 ("Hurts Little More"), 6 ("Hurts Even More"), and 8 ("Hurts Whole Lot."). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain).

Time frame: immediately after administration of intranasal midazolam

Data from ClinicalTrials.gov

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