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

Primary Purpose

Leukemia, Non Hodgkin Lymphoma

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Livopan
Livopan
EMLA
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma

Eligibility Criteria

4 Years - 14 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

EMLA and Livopan

EMLA and gas placebo

Livopan and placebo cream

Arm Description

Administered EMLA and Livopan

Administered EMLA and oxygen

Administered Livopan and placebo cream

Outcomes

Primary Outcome Measures

Compare analgesic efficacy of EMLA versus Nitrous oxide

Secondary Outcome Measures

Evaluate analgesic synergism of EMLA versus nitrous oxide

Full Information

First Posted
December 12, 2008
Last Updated
July 25, 2014
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT00808171
Brief Title
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Non Hodgkin Lymphoma
Keywords
lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMLA and Livopan
Arm Type
Experimental
Arm Description
Administered EMLA and Livopan
Arm Title
EMLA and gas placebo
Arm Type
Experimental
Arm Description
Administered EMLA and oxygen
Arm Title
Livopan and placebo cream
Arm Type
Experimental
Arm Description
Administered Livopan and placebo cream
Intervention Type
Drug
Intervention Name(s)
Livopan
Other Intervention Name(s)
equimolar mixture of nitrous oxide/oxygen
Intervention Description
Inhalation of oxygen and nitrous oxide 50%
Intervention Type
Drug
Intervention Name(s)
Livopan
Other Intervention Name(s)
equimolar mixture of nitrous oxide/oxygen
Intervention Description
equimolar mixture of N2O/O2
Intervention Type
Drug
Intervention Name(s)
EMLA
Other Intervention Name(s)
Eutetic mixture of local anesthetics lidocaine/prilocaine
Intervention Description
Lidocaine-prilocain cream
Primary Outcome Measure Information:
Title
Compare analgesic efficacy of EMLA versus Nitrous oxide
Time Frame
Within first hour after the procedures
Secondary Outcome Measure Information:
Title
Evaluate analgesic synergism of EMLA versus nitrous oxide
Time Frame
One hour after the procedures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16999723
Citation
Steedman B, Watson J, Ali S, Shields ML, Patmore RD, Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow examination. Clin Lab Haematol. 2006 Oct;28(5):321-4. doi: 10.1111/j.1365-2257.2006.00807.x.
Results Reference
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Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture

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