N/A N=60 Randomized Triple-blind Treatment

Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01224431 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Pain, Measured as Units on a Scale — 4.0; 4.8 units on scale, 0-5

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Buffered Lidocaine J-tip (Drug)
Age: Pediatric
Sex: All
Sponsor: Phoenix Children's Hospital
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain, Measured as Units on a Scale	4.0; 4.8	—
SECONDARY Length of Cry	38.53; 48.76	—

Summary

Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

Eligibility Criteria

Inclusion Criteria

fever in infants less than 3 months

Exclusion Criteria

toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight

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Data sourced from ClinicalTrials.gov (NCT01224431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.