NCT02465255

Sublingual Analgesia for Acute Abdominal Pain in Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Pain

Interventions

Type	Name	Description
DRUG	Ketorolac
DRUG	Tramadol
DRUG	Acetaminophen

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-06-08
• Last updated: 2017-08-22

Locations

1 site across 1 country: Italy