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

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Non Hodgkin Lymphoma; Leukemia

Treatments: Drug: Livopan; Drug: EMLA

Study type: Interventional

Funder types: Other

Identifiers

NCT00808171

CAAE0450020300008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups

EMLA and Livopan

Experimental group

Description:

Administered EMLA and Livopan

Treatment:

Drug: EMLA

Drug: Livopan

Drug: Livopan

EMLA and gas placebo

Experimental group

Description:

Administered EMLA and oxygen

Treatment:

Drug: EMLA

Livopan and placebo cream

Experimental group

Description:

Administered Livopan and placebo cream

Treatment:

Drug: Livopan

Drug: Livopan