Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
Information source: Federal University of Minas Gerais
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Non Hodgkin Lymphoma
Intervention: Livopan (Drug); Livopan (Drug); EMLA (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Federal University of Minas Gerais Official(s) and/or principal investigator(s):
Yerkes P Silva, PhD, Principal Investigator, Affiliation: Federal University of Minas Gerais
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Compare analgesic efficacy of EMLA versus Nitrous oxide
Secondary outcome: Evaluate analgesic synergism of EMLA versus nitrous oxide
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
Minimum age: 4 Years.
Maximum age: 14 Years.
Gender(s): Both.
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.
Locations and Contacts
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
Additional Information
Related 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.
Starting date: February 2009
Last updated: July 25, 2014
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