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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Leukemia Non Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EMLA and Livopan

Administered EMLA and Livopan

Group Type EXPERIMENTAL

Livopan

Intervention Type DRUG

Inhalation of oxygen and nitrous oxide 50%

EMLA

Intervention Type DRUG

Lidocaine-prilocain cream

EMLA and gas placebo

Administered EMLA and oxygen

Group Type EXPERIMENTAL

EMLA

Intervention Type DRUG

Lidocaine-prilocain cream

Livopan and placebo cream

Administered Livopan and placebo cream

Group Type EXPERIMENTAL

Livopan

Intervention Type DRUG

equimolar mixture of N2O/O2

Interventions

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Livopan

Inhalation of oxygen and nitrous oxide 50%

Intervention Type DRUG

Livopan

equimolar mixture of N2O/O2

Intervention Type DRUG

EMLA

Lidocaine-prilocain cream

Intervention Type DRUG

Other Intervention Names

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equimolar mixture of nitrous oxide/oxygen equimolar mixture of nitrous oxide/oxygen Eutetic mixture of local anesthetics lidocaine/prilocaine

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes