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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808171
• Other study ID #: CAAE0450020300008
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2008
• Last updated: July 25, 2014
• Start date: February 2009
• Est. completion date: August 2011

Study information

• Verified date: July 2014
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• Livopan
Inhalation of oxygen and nitrous oxide 50%
• Livopan
equimolar mixture of N2O/O2
• EMLA
Lidocaine-prilocain cream

Locations

Country	Name	City	State
Brazil	Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare analgesic efficacy of EMLA versus Nitrous oxide		Within first hour after the procedures	Yes
Secondary	Evaluate analgesic synergism of EMLA versus nitrous oxide		One hour after the procedures	Yes