A Phase 4 interventional study of Livopan and Livopan in Leukemia and Non Hodgkin Lymphoma, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 4 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-29.
Sponsored by Federal University of Minas Gerais · Phase 4, Interventional, and Supportive care
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.
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.
1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.
This study's enrollment of 52 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
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Administered EMLA and Livopan
Drug: Livopan · Drug: EMLA
Administered EMLA and oxygen
Drug: EMLA
Administered Livopan and placebo cream
Drug: Livopan
Inhalation of oxygen and nitrous oxide 50%
Also known as: equimolar mixture of nitrous oxide/oxygen
equimolar mixture of N2O/O2
Also known as: equimolar mixture of nitrous oxide/oxygen
Lidocaine-prilocain cream
Also known as: Eutetic mixture of local anesthetics lidocaine/prilocaine
Compare analgesic efficacy of EMLA versus Nitrous oxide
Time frame: Within first hour after the procedures
Evaluate analgesic synergism of EMLA versus nitrous oxide
Time frame: One hour after the procedures
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Federal University of Minas Gerais