Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | July 2014 |
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 is often needed in newborns to obtain
cerebrospinal fluid. 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.
performing a lumbar puncture. A lumbar puncture is often needed in newborns to obtain
cerebrospinal fluid. 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.
When the decision is made that an infant needs a lumbar puncture for clinical indications,
parental consent will be obtained for the actual procedure and a separate consent for
participation in this study will be attached. Randomization for this study will be via
permuted block randomization. The expected 122 patients will be pre-randomized, with the arm
for each patient number 1 through 122 sealed in an envelope. After consent is obtained the
patient will be assigned the next numerical study identification number and the
corresponding envelope will be opened. If the infant has been randomized to the topical
liposomal lidocaine group, 1 gram of LMX-4 will be placed over the L3-L4 space immediately,
covered with a cotton ball and occlusive tegaderm, for minimum 30 minutes prior to the
needle insertion during the lumbar puncture. While the LMX-4 is in place, other procedures
that are part of a routine septic work-up may be performed. Thus, the application of this
medication should not cause an unnecessary delay in the ultimate procedure or antibiotic
administration.
If the infant has been randomized to the subcutaneous lidocaine group, after using sterile
procedure to prepare the area, 0.1ml/kg of 1% Lidocaine will be injected using a 25 gauge
tuberculin needle over the L3-L4 region. The injection point will be below the actual level
desired with the needle going in at a 5-10 degree angle and moving toward the head after
insertion. A subcutaneous wheal will form over the desired L3-L4 space when the Lidocaine is
injected. The provider will wait at minimum 2 minutes after the injection of the Lidocaine
prior to the insertion of the LP needle. Once the required time for local anesthesia in
either arm has elapsed, the procedure will be performed with routine technique.
With consent for the video portion of the study, a video camera will be set up to tape the
infants face only during the procedure with notation of the LP needle insertion(s). During
the procedure, an assistant will record heart rate and oxygen saturation values. The
information from the video and documented vital signs will be used to assign a PIPP score by
a blinded investigator. Once the procedure is complete the following information will be
obtained for study purposes, in addition to the above video tape and vital signs: infant
gestational age, infant birth weight, gender, day of life of procedure, level of provider(s)
performing the procedure, attempts required to obtain CSF specimen, color of fluid (clear,
pink, xanthochromic, or grossly bloody), presence of CSF culture, and Red Blood Cell count
of CSF specimen. Infants in our institution will already be monitored continuously and will
continue to be so for at minimum 6 hours after the procedure. Any adverse reaction that
could be attributed to the procedure or medications used for the procedure will be recorded,
with the most expected reaction to be a skin rash. Additional changes in the infant, such as
apnea, sustained arrhythmia, oxygen desaturation 10% below baseline, or seizure will also be
noted whether or not it is thought to be associated with the procedure.
parental consent will be obtained for the actual procedure and a separate consent for
participation in this study will be attached. Randomization for this study will be via
permuted block randomization. The expected 122 patients will be pre-randomized, with the arm
for each patient number 1 through 122 sealed in an envelope. After consent is obtained the
patient will be assigned the next numerical study identification number and the
corresponding envelope will be opened. If the infant has been randomized to the topical
liposomal lidocaine group, 1 gram of LMX-4 will be placed over the L3-L4 space immediately,
covered with a cotton ball and occlusive tegaderm, for minimum 30 minutes prior to the
needle insertion during the lumbar puncture. While the LMX-4 is in place, other procedures
that are part of a routine septic work-up may be performed. Thus, the application of this
medication should not cause an unnecessary delay in the ultimate procedure or antibiotic
administration.
If the infant has been randomized to the subcutaneous lidocaine group, after using sterile
procedure to prepare the area, 0.1ml/kg of 1% Lidocaine will be injected using a 25 gauge
tuberculin needle over the L3-L4 region. The injection point will be below the actual level
desired with the needle going in at a 5-10 degree angle and moving toward the head after
insertion. A subcutaneous wheal will form over the desired L3-L4 space when the Lidocaine is
injected. The provider will wait at minimum 2 minutes after the injection of the Lidocaine
prior to the insertion of the LP needle. Once the required time for local anesthesia in
either arm has elapsed, the procedure will be performed with routine technique.
With consent for the video portion of the study, a video camera will be set up to tape the
infants face only during the procedure with notation of the LP needle insertion(s). During
the procedure, an assistant will record heart rate and oxygen saturation values. The
information from the video and documented vital signs will be used to assign a PIPP score by
a blinded investigator. Once the procedure is complete the following information will be
obtained for study purposes, in addition to the above video tape and vital signs: infant
gestational age, infant birth weight, gender, day of life of procedure, level of provider(s)
performing the procedure, attempts required to obtain CSF specimen, color of fluid (clear,
pink, xanthochromic, or grossly bloody), presence of CSF culture, and Red Blood Cell count
of CSF specimen. Infants in our institution will already be monitored continuously and will
continue to be so for at minimum 6 hours after the procedure. Any adverse reaction that
could be attributed to the procedure or medications used for the procedure will be recorded,
with the most expected reaction to be a skin rash. Additional changes in the infant, such as
apnea, sustained arrhythmia, oxygen desaturation 10% below baseline, or seizure will also be
noted whether or not it is thought to be associated with the procedure.
Inclusion Criteria:
- neonate requiring lumbar puncture
- gestational age at birth equal to or greater than 34 weeks
Exclusion Criteria:
- on mechanical ventilation
- receiving sedation (opioids or benzodiazepines)
- suspected congenital spinal anomaly
- infants older than 1 week of life
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