Conditions: Pain
Keywords: pain lumbar puncture neonates infants emergency department topical anesthesia LMX4
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Detailed description:
Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.

Arms:
arm 1: Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing arm 2: Placebo Cream made on same run at factory but without active Lidocaine 4% drug

Interventions: intervention 1: Lidocaine Cream 4% intervention 2: Placebo
Intervention descriptions: intervention 1: Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure intervention 2: inactive placebo without LMX4

Protocol document: