drugset / Trial / NCT02465255

Sublingual Analgesia for Acute Abdominal Pain in Children

NCT02465255

Phase 3 Completed 210 enrolled IRCCS Burlo Garofolo
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-03
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 20 mg/kg Other
Subject Ketorolac Other / unclassified 0.5 mg/kg Other
Comparator Tramadol Other / unclassified 2 mg/kg Other

Indications

No indication recorded.