"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

University at Buffalo (UB)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Lidocaine Cream 4%; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00533468

05-130

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: Under 60 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full term (>=37 weeks gestation)
• Age 0-60 Days
• Undergoing Lumbar Puncture

Exclusion criteria

• Unstable
• Premature (<37 weeks gestation)
• Allergy to study medicine
• Parent refusal of consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Active Drug

Experimental group

Description:

Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing

Treatment:

Drug: Lidocaine Cream 4%

Placebo

Placebo Comparator group

Description:

Placebo Cream made on same run at factory but without active Lidocaine 4% drug

Treatment:

Drug: Placebo