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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time frame: 120 minutes after drug administration
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time frame: 30 minutes after drug administration
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time frame: 60 minutes after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time frame: 24 hours after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time frame: 48 hours after drug administration
Adverse events
Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding
Time frame: up to 180 hours after the drug administration
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