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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Compare analgesic efficacy of EMLA versus Nitrous oxide
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between four and 14 years;
- •Not present cognitive disabilities;
- •Necessity to perform the clinical procedure;
- •Accordance in participating in the study.
排除标准
- •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.
研究组 & 干预措施
EMLA and Livopan
Administered EMLA and Livopan
干预措施: Livopan (Drug)
EMLA and Livopan
Administered EMLA and Livopan
干预措施: EMLA (Drug)
EMLA and gas placebo
Administered EMLA and oxygen
干预措施: EMLA (Drug)
Livopan and placebo cream
Administered Livopan and placebo cream
干预措施: Livopan (Drug)
结局指标
主要结局
Compare analgesic efficacy of EMLA versus Nitrous oxide
时间窗: Within first hour after the procedures
次要结局
- Evaluate analgesic synergism of EMLA versus nitrous oxide(One hour after the procedures)
研究者
Renato Santiago Gomez
PhD
Federal University of Minas Gerais