Clinical Trial: Sublingual Analgesia for Acute Abdominal Pain in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial

Brief Summary:

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.


Detailed Summary:
Sponsor: IRCCS Burlo Garofolo

Current Primary Outcome: Pain Score [ Time Frame: 120 minutes after drug administration ]

Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain Score [ Time Frame: 30 minutes after drug administration ]
    Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
  • Pain Score [ Time Frame: 60 minutes after drug administration ]
    Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
  • 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 [ Time Frame: up to 180 hours after the drug administration ]
    Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding


Original Secondary Outcome: Same as current

Information By: IRCCS Burlo Garofolo

Dates:
Date Received: June 3, 2015
Date Started: March 2015
Date Completion: March 2017
Last Updated: November 17, 2016
Last Verified: November 2016