Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture and Myelogram
Recruitment status was Not yet recruiting
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 and myelogram.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|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 and Myelogram|
- Compare analgesic efficacy of EMLA versus Nitrous oxide [ Time Frame: Within first hour after the procedures ] [ Designated as safety issue: Yes ]
- Evaluate analgesic synergism of EMLA versus nitrous oxide [ Time Frame: One hour after the procedures ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: nitrous oxide
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.
|Contact: Yerkes Pereira Silva, PhD||0055 31 9993 firstname.lastname@example.org|
|Contact: Claudirene Milagres Araujo, RN||0055 31 9903 email@example.com|
|Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais||Not yet recruiting|
|Belo Horizonte, Minas Gerais, Brazil|
|Contact: Claudirene M Araujo, RN 0055 31 99032405 firstname.lastname@example.org|
|Principal Investigator: Claudirene M Araujo, RN|
|Principal Investigator:||Yerkes Pereira Silva, PhD||Federal University of Minas Gerais|