CompletedPhase 4

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

United States70 participantsStarted 2007-03

Plain-language summary

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

Who can participate

Age range0 Days – 60 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neonatal Facial Coding System Score

Timeframe: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled

Trial details

NCT IDNCT00533468

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2020-09-07

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