Leukemia Clinical Trial
Official title:
Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture
In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.
It is a randomized controlled clinical trial, double blinded, with the purpose to compare
the use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50%
in oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years
old submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the
Wong Baker faces scale and the visual numeric scale during six observational periods:
baseline; three minutes after gas administration and before the first attempt of lumbar
puncture; during the first lumbar puncture attempt; during the chemotherapy administration;
during needle remove and three minutes after gas interruption. All the studied procedures
will have clinical indication and will not be held by the researcher. The children was
random divided within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group
B (n=19)EMLA + gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.
Primary outcome was the detection of a difference of 20% or more in the visual numeric scale
between the three treatment groups during the first attempt of lumbar puncture.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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