N/A
Completed N=60
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
Source: ClinicalTrials.gov NCT01224431 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Pain, Measured as Units on a Scale — 4.0; 4.8 units on scale, 0-5
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.
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 | — |
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
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. Informational only — not medical advice.