Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 leukemia
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJuly 29, 2014
July 1, 2014
2.5 years
December 12, 2008
July 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare analgesic efficacy of EMLA versus Nitrous oxide
Within first hour after the procedures
Secondary Outcomes (1)
Evaluate analgesic synergism of EMLA versus nitrous oxide
One hour after the procedures
Study Arms (3)
EMLA and Livopan
EXPERIMENTALAdministered EMLA and Livopan
EMLA and gas placebo
EXPERIMENTALAdministered EMLA and oxygen
Livopan and placebo cream
EXPERIMENTALAdministered Livopan and placebo cream
Interventions
Eligibility Criteria
You may qualify if:
- Age between four and 14 years;
- Not present cognitive disabilities;
- Necessity to perform the clinical procedure;
- Accordance in participating in the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Related Publications (1)
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.
PMID: 16999723BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yerkes P Silva, PhD
Federal University of Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 12, 2008
First Posted
December 15, 2008
Study Start
February 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
July 29, 2014
Record last verified: 2014-07