Lumbar puncture (LP) is a procedure performed frequently among children in the emergency department (ED). Although it has been performed for decades, and for distinct indications, the technique itself can often lead to traumatic results, which can complicate its interpretation and lead to over-treatments and hospitalizations. Several factors have been suggested to improve the success rate of LPs. Among them, the stylet-out (SO), also known as the early stylet removal technique, has been suggested but not properly studied. The aim of this study is to evaluate whether the stylet-out technique can reduce the probability of failure or traumatic lumbar puncture procedures in a pediatric population presenting to the emergency department as compared to the standard stylet-in (SI) approach. To achieve this goal, the investigator will conduct a randomized controlled trial comparing the SO versus SI techniques in a tertiary care, pediatric, university-affiliated emergency. All children younger than 18 years of age requiring a LP as part of their ED workup will be eligible and randomized to either the standard SI or SO group. The primary outcome will be the first-attempt LP success rate as defined by the minimum amount of cerebrospinal fluid (CSF) necessary to perform a leukocyte count and bacterial/viral CSF cultures, according to each laboratory with red blood cell count \< 1000/mm3. Secondary outcomes will include the following: overall LP success rate (i.e. despite number of attempts), proportion of traumatic LP, number of LP attempts, number of changes in providers performing the LP, proportion of traumatic LP, total time to procedure, mean difference in pain scores and satisfaction rates in both groups. The hypothesis is that the use of the Stylet Out approach will reduce the number of failed and traumatic LP in the pediatric population presenting to the ED as compared to the standard SI approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
395
This method consists of inserting the needle with the stylet-in, then only remove the stylet once the desired depth is achieved and CSF flow is expected. If no CSF comes back, the stylet is replaced before continuing to advance the needle until the subarachnoid space is entered. This is the technique generally used in our emergency department and will serve as the control treatment group.
This method consists of inserting the needle through the epidermis and the dermis, which is estimated as a 0.5 to 1 cm length in children, then remove the stylet before progressing through the other structures until the subarachnoid space is entered. This approach will be used in the experimental technique group.
CHU Sainte-Justine
Montreal, Quebec, Canada
RECRUITINGFirst-time lumbar puncture success rate
Defined as the minimum amount of CSF necessary to perform a leukocyte count and a CSF bacterial/viral culture, according to the hospital laboratory, with a red blood cell count \<1,000/mm3
Time frame: 1 hour after procedure
Lumbar puncture success rate despite the number of attempts
Defined as the minimum amount of CSF necessary to perform a leukocyte count and CSF bacterial/viral culture according to each laboratory with red blood cell count \<1,000/mm3
Time frame: 1 hour after procedure
Proportion of final traumatic lumbar puncture
Defined as a red blood cell count \> 1,000/mm3 not explained by a concomitant meningitis diagnosis (i.e. negative culture)
Time frame: 1 hour after procedure
Number of lumbar puncture attempts in total
Defined as any time a needle that is completely outside the body penetrates the skin
Time frame: immediately after procedure
Number of changes in provider performing the lumbar puncture
The first provider could be a trainee, and then a trained physician
Time frame: immediately after procedure
Length of procedure
Measured from the time the needle pierces the skin until first drop of CSF
Time frame: immediately after procedure
Mean difference in Evendol pain scores and NRS-11 scores
Evendol pain scores will be applied for all patients and NRS-11 will be applied for children 6 years and older remembering the procedure
Time frame: during procedure
Satisfaction with procedure
LP provider satisfaction as measured by a five-point Likert Scale
Time frame: immediately after procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.