Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Lidocaine; Drug: Midazolam; Drug: 0.9% Saline

• Registration Number: NCT02396537
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Results First Submitted: 2016-08-09
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Lidocaine	Midazolam	Patient to receive 4% lidocaine intranasally prior to midazolam
Intranasal Lidocaine	Lidocaine	Patient to receive 4% lidocaine intranasally prior to midazolam
Intranasal 0.9% saline	0.9% Saline	Patient to receive 0.9% Saline intranasally prior to midazolam
Intranasal 0.9% saline	Midazolam	Patient to receive 0.9% Saline intranasally prior to midazolam

Primary Outcome Measures

Name	Time	Method
Discomfort With Intranasal Midazolam Administration	immediately after administration of intranasal midazolam	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).