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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Federal University of Minas Gerais.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00808171
First received: December 12, 2008
Last updated: December 15, 2008
Last verified: December 2008
  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 and myelogram.


Condition Intervention Phase
Leukemia
Non Hodgkin Lymphoma
Drug: nitrous oxide
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 and Myelogram

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 ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: nitrous oxide
    Inhalation of oxygen and nitrous oxide 50%
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 14 years old submitted to lumbar puncture and myelogram. The evaluation will be done based on a valid pain scale (face scale or visual numeric scale - VNS) during well-known painful procedures (lumbar puncture and myelogram) that will take place in the Hematologic Pediatric Ambulatory from Hospital das Clinicas at the University of Minas Gerais (UFMG). All the studied procedures will have clinical indication and will not be held by the researcher. One of the researches will be responsible for the drugs and/or placebo administration and another researcher will be responsible for pain and stress evaluation during the procedures. The children will be aleatorily divided within three groups A, B and C as follow: Group A (n=40)EMLA + Oxygen (lumbar puncture; n=20 and myelograms; n=20); Group B (n=40)EMLA + Livopan®, (lumbar puncture; n=20 and myelograms; n=20); Group C (n=40) Livopan® + placebo cream, (lumbar puncture; n=20 and myelogram; n=20.

All children will undergo a therapeutic proposal, moreover the purpose of this study is to valid not only control measures application but also pain treatment while performing these well-known painful procedures. According to the clinical practice, although those procedures are necessary and frequent, unfortunately, a few or none medical intervention is performed.

  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

Contacts
Contact: Yerkes Pereira Silva, PhD 0055 31 9993 3384 yerkesps@uol.com.br
Contact: Claudirene Milagres Araujo, RN 0055 31 9903 2405 claudirene_milagres@hotmail.com

Locations
Brazil
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Claudirene M Araujo, RN    0055 31 99032405    claudirene_milagres@hotmail.com   
Principal Investigator: Claudirene M Araujo, RN         
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Yerkes Pereira 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: Yerkes Pereira e Silva, 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: December 15, 2008
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:
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014