Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leukemia, Non Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Livopan
* Drug: Livopan
* Drug: EMLA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMLA and Livopan<br>Administered EMLA and Livopan | Drug: Livopan<br>* Inhalation of oxygen and nitrous oxide 50%<br>* Other names: equimolar mixture of nitrous oxide/oxygen;Drug: EMLA<br>* Lidocaine-prilocain cream<br>* Other names: Eutetic mixture of local anesthetics lidocaine/prilocaine;|
| Experimental: EMLA and gas placebo<br>Administered EMLA and oxygen | Drug: EMLA<br>* Lidocaine-prilocain cream<br>* Other names: Eutetic mixture of local anesthetics lidocaine/prilocaine;|
| Experimental: Livopan and placebo cream<br>Administered Livopan and placebo cream | Drug: Livopan<br>* equimolar mixture of N2O/O2<br>* Other names: equimolar mixture of nitrous oxide/oxygen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare analgesic efficacy of EMLA versus Nitrous oxide |  | Within first hour after the procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate analgesic synergism of EMLA versus nitrous oxide |  | One hour after the procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma