Conditions: Pain
Keywords: Children Midazolam Lidocaine Intranasal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: yes

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.

Arms:
arm 1: Patient to receive 4% lidocaine intranasally prior to midazolam arm 2: Patient to receive 0.9% Saline intranasally prior to midazolam

Interventions: intervention 1: Lidocaine intervention 2: Midazolam intervention 3: 0.9% Saline
Intervention descriptions: intervention 1: Administered intranasally prior to Midazolam administration. intervention 2: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. intervention 3: Administered intranasally prior to Midazolam administration.

Protocol document: