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
Overview
- Phase
- Phase 4
- Intervention
- Livopan
- Conditions
- Leukemia
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Compare analgesic efficacy of EMLA versus Nitrous oxide
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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.
Investigators
Renato Santiago Gomez
PhD
Federal University of Minas Gerais
Eligibility 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.
Arms & Interventions
EMLA and Livopan
Administered EMLA and Livopan
Intervention: Livopan
EMLA and Livopan
Administered EMLA and Livopan
Intervention: EMLA
EMLA and gas placebo
Administered EMLA and oxygen
Intervention: EMLA
Livopan and placebo cream
Administered Livopan and placebo cream
Intervention: Livopan
Outcomes
Primary Outcomes
Compare analgesic efficacy of EMLA versus Nitrous oxide
Time Frame: Within first hour after the procedures
Secondary Outcomes
- Evaluate analgesic synergism of EMLA versus nitrous oxide(One hour after the procedures)