Lidocaine
DrugAdministered intranasally prior to Midazolam administration.
Other names: Xylocaine
NCT Number: NCT02396537
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.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered intranasally prior to Midazolam administration.
Other names: Xylocaine
Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
Other names: Versed
Administered intranasally prior to 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).
University of Alabama at Birmingham
Other
Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration: A Double-blind, Randomized, Placebo-controlled Trial
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