Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

The University of Alabama at Birmingham

Status: Completed

Conditions: Pain

Treatments: Drug: 0.9% Saline; Drug: Midazolam; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02396537

F130917005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups, including a placebo group

Intranasal Lidocaine

Experimental group

Description:

Patient to receive 4% lidocaine intranasally prior to midazolam

Treatment:

Drug: Lidocaine

Drug: Midazolam

Intranasal 0.9% saline

Placebo Comparator group

Description:

Patient to receive 0.9% Saline intranasally prior to midazolam

Treatment:

Drug: Midazolam

Drug: 0.9% Saline