Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Study Overview
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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.

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.

Official Title
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Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration: A Double-blind, Randomized, Placebo-controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Midazolam
* Drug: 0.9% Saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Lidocaine<br>Patient to receive 4% lidocaine intranasally prior to midazolam | Drug: Lidocaine<br>* Administered intranasally prior to Midazolam administration.<br>* Other names: Xylocaine;Drug: Midazolam<br>* Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.<br>* Other names: Versed;|
| Placebo Comparator: Intranasal 0.9% saline<br>Patient to receive 0.9% Saline intranasally prior to midazolam | Drug: Midazolam<br>* Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.<br>* Other names: Versed;Drug: 0.9% Saline<br>* Administered intranasally prior to Midazolam administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | immediately after administration of intranasal midazolam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Midazolam, Lidocaine, Intranasal