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NCT01606150 · ClinicalTrials.gov registry record · NA
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
A NA study, sponsored by Georgetown University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01606150 is a NA study that was terminated before completion, run by Georgetown University. The registered enrollment target is 5 participants.
The verdict
NCT01606150, a NA study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's vertebrae. In the past, doctors did not know if newborns could feel the pain from a procedure like this in the same way that adults do. Investigators now know that the newborns do experience pain during this procedure, but we do not know the best way to control this pain. Investigators also think that when the newborns have pain, they move during the test. The movement can increase the chance of having blood mix with this normally clear fluid leading to limitations in our clinical application of these results. This study will compare the injected and topical forms of Lidocaine to see which gives us better pain control and more clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the rate of clinically useful results and pain scores. The investigators hypothesize that both forms of Lidocaine will be 25% superior to our historical control cohort in the rate of clinically useful results.
Interventions
- DRUG topical lidocaine
- DRUG 1% lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01606150
The ClinicalTrials.gov registry entry for NCT01606150 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which topical lidocaine is the first listed.
NCT01606150 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01606150 about?
NCT01606150 is a clinical study titled "Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain". The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's vertebrae. In the past, d...
What is the current status of trial NCT01606150?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2012-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01606150?
The interventions under investigation include: topical lidocaine (DRUG), 1% lidocaine (DRUG).
Who is sponsoring clinical trial NCT01606150?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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