Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
Acute abdominal pain is a frequent symptom in children admitted to the emergency department . In the past the fear of masking a surgical condition has justified withholding analgesia in patients with acute abdominal pain. By the 2000s, some clinical trials established that opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome in children with acute abdominal pain. Despite this, acute abdominal pain is still undertreated in this setting. Published paediatric trials studied the effect of opioid analgesia administered by parenteral route or by mouth. To the best of our knowledge no study investigated the effectiveness of sublingual analgesia.
The purpose of this randomized controlled trial is to assess the effectiveness of three different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in children complaining of acute abdominal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 18 years
- •Emergency department admission for moderate to severe acute abdominal pain (VAS/NRS score >=6)
- •Informed consent signed by parents or legal guardians
排除标准
- •Known allergy or sensitivity to nonsteroidal anti-inflammatory drug, opioids or acetaminophen
- •Use of analgesic drugs in the 8 hours before
- •Clinical suspicion of abdominal pain due to fecal stasis
- •Moderate or severe dehydration (weight loss of more than 5%)
- •Known nephropathy, liver disease, metabolic or neurologic disease
- •Thrombocytopenia or history of bleeding disease
研究组 & 干预措施
Ketorolac
Ketorolac 0.5 mg/kg administrated by sublingual route
干预措施: Ketorolac (Drug)
Tramadol
Tramadol 2.0 mg/kg administrated by sublingual route
干预措施: Tramadol (Drug)
Acetaminophen (paracetamol)
Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pain Score
时间窗: 120 minutes after drug administration
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
次要结局
- Pain Score(60 minutes after drug administration)
- Adverse events(up to 180 hours after the drug administration)
- Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)(48 hours after drug administration)
研究者
Luca Ronfani
MD, PhD
IRCCS Burlo Garofolo