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

July 25, 2014 updated by: Renato Santiago Gomez, Federal University of Minas Gerais

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE0450020300008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe