Trial Information

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 and Myelogram

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 14 years
old submitted to lumbar puncture and myelogram. The evaluation will be done based on a valid
pain scale (face scale or visual numeric scale - VNS) during well-known painful procedures
(lumbar puncture and myelogram) that will take place in the Hematologic Pediatric Ambulatory
from Hospital das Clinicas at the University of Minas Gerais (UFMG). All the studied
procedures will have clinical indication and will not be held by the researcher. One of the
researches will be responsible for the drugs and/or placebo administration and another
researcher will be responsible for pain and stress evaluation during the procedures. The
children will be aleatorily divided within three groups A, B and C as follow: Group A
(n=40)EMLA + Oxygen (lumbar puncture; n=20 and myelograms; n=20); Group B (n=40)EMLA +
Livopan®, (lumbar puncture; n=20 and myelograms; n=20); Group C (n=40) Livopan® + placebo
cream, (lumbar puncture; n=20 and myelogram; n=20.

All children will undergo a therapeutic proposal, moreover the purpose of this study is to
valid not only control measures application but also pain treatment while performing these
well-known painful procedures. According to the clinical practice, although those procedures
are necessary and frequent, unfortunately, a few or none medical intervention is performed.