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NCT01224431 · ClinicalTrials.gov registry record · NA
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
A NA study, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01224431: Completed NA study, sponsored by Phoenix Children's Hospital.
NCT01224431 is a NA study that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224431, a NA study, has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible
Interventions
- DRUG Buffered Lidocaine J-tip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-06 |
| Phase | NA |
What the finished NCT01224431 record still lists
NCT01224431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Buffered Lidocaine J-tip is the first listed.
NCT01224431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01224431 about?
NCT01224431 is a clinical study titled "Needle-Free Jet Injection of Lidocaine During Lumbar Puncture". 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 i...
What is the current status of trial NCT01224431?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2009-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01224431?
The interventions under investigation include: Buffered Lidocaine J-tip (DRUG).
Who is sponsoring clinical trial NCT01224431?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01224431's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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