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Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain

NCT01606150 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-12-13

Study results available
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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.

Conditions

Interventions

DRUG

1% lidocaine

0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure

DRUG

topical lidocaine

1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Judith J PALAFOUTAS, RN · Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Max Age
8 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606150 on ClinicalTrials.gov