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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00808171
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Leukemia Non Hodgkin Lymphoma Drug: Livopan Drug: EMLA Phase 4

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  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : February 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EMLA and Livopan
Administered EMLA and Livopan
Drug: Livopan
Inhalation of oxygen and nitrous oxide 50%
Other Name: equimolar mixture of nitrous oxide/oxygen

Drug: EMLA
Lidocaine-prilocain cream
Other Name: Eutetic mixture of local anesthetics lidocaine/prilocaine

Experimental: EMLA and gas placebo
Administered EMLA and oxygen
Drug: EMLA
Lidocaine-prilocain cream
Other Name: Eutetic mixture of local anesthetics lidocaine/prilocaine

Experimental: Livopan and placebo cream
Administered Livopan and placebo cream
Drug: Livopan
equimolar mixture of N2O/O2
Other Name: equimolar mixture of nitrous oxide/oxygen

Primary Outcome Measures :
  1. Compare analgesic efficacy of EMLA versus Nitrous oxide [ Time Frame: Within first hour after the procedures ]

Secondary Outcome Measures :
  1. Evaluate analgesic synergism of EMLA versus nitrous oxide [ Time Frame: One hour after the procedures ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00808171

Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Principal Investigator: Yerkes P Silva, PhD Federal University of Minas Gerais

Harrop JE. Management of pain in childhood. Arch Dis Child Educ Prat Ed. 2007 Aug;92(4):ep101-8. Williams V, Riley A, Rayner R, Richardson K. Inhaled Nitrous Oxide During Painful Procedures: A Satisfaction Survey. Pediatric Nursing 2006 October;18(8):31-3. Steedman B, Watson J, Ali S, Shileds ML, Patmore RD, Allsup DJ. Inhaled Nitrous Oxide (Entonox) as a Short Acting Sedative During Bone Marrow Examination. Clin Lab Haem 2006 Oct;28(5):321-4.

Responsible Party: Renato Santiago Gomez, PhD, Federal University of Minas Gerais Identifier: NCT00808171     History of Changes
Other Study ID Numbers: CAAE0450020300008
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Renato Santiago Gomez, Federal University of Minas Gerais:
lumbar punction
pain assessment
nitrous oxide and EMLA
Leukemia and non Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anesthetics, Local
Nitrous Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Anesthetics, Combined