Clinical trial NCT00808171: Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leukemia
Non Hodgkin Lymphoma
Keywords: lumbar punction
myelogram
pain assessment
nitrous oxide and EMLA
Leukemia and non Hodgkin lymphoma
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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®) 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.

Eligibility criteria: Inclusion Criteria:

* Age between four and 14 years;
* Not present cognitive disabilities;
* Necessity to perform the clinical procedure;
* Accordance in participating in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compare analgesic efficacy of EMLA versus Nitrous oxide
timeFrame: Within first hour after the procedures
Secondary outcomes:
measure: Evaluate analgesic synergism of EMLA versus nitrous oxide
timeFrame: One hour after the procedures
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Yerkes P Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steedman B, Watson J, Ali S, Shields ML, Patmore RD, Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow examination. Clin Lab Haematol. 2006 Oct;28(5):321-4. doi: 10.1111/j.1365-2257.2006.00807.x.