Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Condition(s) targeted: Pain

Intervention: Lidocaine (Drug); Midazolam (Drug); 0.9% Saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
David Smith, MD, Principal Investigator, Affiliation: UAB Department of Pediatrics

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Pain felt during administration of Midazolam

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.

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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.

Starting date: January 2014
Last updated: March 17, 2015