NCT00808171

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Leukemia
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Livopan	Inhalation of oxygen and nitrous oxide 50%
DRUG	Livopan	equimolar mixture of N2O/O2
DRUG	EMLA	Lidocaine-prilocain cream

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-12-15
• Last updated: 2014-07-29

Locations

1 site across 1 country: Brazil