Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration: A Double-blind, Randomized, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 77
- Primary Endpoint
- Discomfort With Intranasal Midazolam Administration
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intranasal Lidocaine
Patient to receive 4% lidocaine intranasally prior to midazolam
Intervention: Lidocaine (Drug)
Intranasal Lidocaine
Patient to receive 4% lidocaine intranasally prior to midazolam
Intervention: Midazolam (Drug)
Intranasal 0.9% saline
Patient to receive 0.9% Saline intranasally prior to midazolam
Intervention: Midazolam (Drug)
Intranasal 0.9% saline
Patient to receive 0.9% Saline intranasally prior to midazolam
Intervention: 0.9% Saline (Drug)
Outcomes
Primary Outcomes
Discomfort With Intranasal Midazolam Administration
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Christopher Pruitt
Pediatric Emergency Medicine Faculty Advisor
University of Alabama at Birmingham