Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.