Status:
COMPLETED
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
Lead Sponsor:
Federal University of Minas Gerais
Conditions:
Leukemia
Non Hodgkin Lymphoma
Eligibility:
All Genders
4-14 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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®...
Eligibility Criteria
Inclusion
- Age between four and 14 years;
- Not present cognitive disabilities;
- Necessity to perform the clinical procedure;
- Accordance in participating in the study.
Exclusion
- Continuity skin lesion in the procedure site;
- Metahemoglobinemia;
- Neuromuscular disability;
- Presence of pneumothorax, emphysema, intra-abdominal infection, cranioencephalic traumatism, otitis media, sinusitis and intracranial hypertension;
- Vitamin B12 known deficits;
- Urgency for the procedure;
- Disagreement in participating of the project;
- Patients in use of Dapsone.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00808171
Start Date
February 1 2009
End Date
August 1 2011
Last Update
July 29 2014
Active Locations (1)
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1
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil