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临床试验/EUCTR2018-004057-25-IT
EUCTR2018-004057-25-IT进行中(未招募)1 期

Oral Ibuprofene versus oral kethorolac for children with musculoskeletal injury: a double blind randomized controlled study. - IbuKet

IRCCS MATERNO INFANTILE BURLO GAROFOLO0 个研究点目标入组 250 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion Criteria: All the following requirements must be met:
  • Present moderate-severe pain (value> = 4 on the NRS scale)
  • Pain must be due to a trauma that has occurred in the last 48 hours
  • Trauma must occur at limbs
  • Age between 8 and 18 years: from the age of 8, until the completion of the eighteen years of age.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Will be excluded from the study every patient that met at list one of the following criteria:
  • Administration of any analgesic in the previous 8 hours.
  • Allergy known to one of the active ingredients
  • Known hepatopathy or nephropathy
  • Suspicion of violence by others
  • Chronic use of painkillers
  • Inability to report pain due to the presence of:
  • or Intellectual disability (IQ & lt; 70)
  • or moderate-severe hearing loss
  • Communication limitations such as patient mutism
  • Unable to write.
  • Inability to speak Italian
  • Chronic neurological or metabolic diseases,
  • Positive history for ease of bleeding, coagulation disorder or
  • thrombocytopenia
  • A history of gastritis or esophagitis in the last 30 days
  • Multiple trauma
  • Vascular-vascular deficit
  • State of pregnancy

研究者

发起方
IRCCS MATERNO INFANTILE BURLO GAROFOLO

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