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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00808171
First received: December 12, 2008
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Leukemia
Non Hodgkin Lymphoma
Drug: Livopan
Drug: EMLA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Compare analgesic efficacy of EMLA versus Nitrous oxide [ Time Frame: Within first hour after the procedures ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate analgesic synergism of EMLA versus nitrous oxide [ Time Frame: One hour after the procedures ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808171

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

Publications:
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
ClinicalTrials.gov Identifier: NCT00808171     History of Changes
Other Study ID Numbers: CAAE0450020300008
Study First Received: December 12, 2008
Last Updated: July 25, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nitrous Oxide
Lidocaine
Anesthetics
EMLA
Anesthetics, Local
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on October 19, 2014