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NCT01628874 · ClinicalTrials.gov registry record · NA
Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
A NA study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT01628874: Clinical Trial NA study, sponsored by University of Colorado, Denver.
NCT01628874 is a NA study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628874, a NA study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic agent (EMLA cream) when performing lumbar punctures in children.
Primary Outcome
The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.
Interventions
- DRUG Lidocaine
- DRUG EMLA
- DEVICE J-Tip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-08 |
| Phase | NA |
Why NCT01628874 stopped before completion
NCT01628874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Lidocaine is the first listed.
NCT01628874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01628874 about?
NCT01628874 is a clinical study titled "Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children". The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide l...
What is the current status of trial NCT01628874?
This trial is currently terminated. It is a NA study. The enrollment target is 66 participants. The study started on 2012-09. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01628874?
The interventions under investigation include: Lidocaine (DRUG), EMLA (DRUG), J-Tip (DEVICE).
Who is sponsoring clinical trial NCT01628874?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01628874's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 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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