Clinical trial NCT02465255: Sublingual Analgesia for Acute Abdominal Pain in Children
Official title: Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Pain
Keywords: Acute Abdominal Pain
Sublingual Analgesia
Children
Ketorolac
Tramadol
Paracetamol
Analgesia
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 210
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Score
timeFrame: 120 minutes after drug administration
Secondary outcomes:
measure: Pain Score
timeFrame: 30 minutes after drug administration
measure: Pain Score
timeFrame: 60 minutes after drug administration
measure: Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
timeFrame: 24 hours after drug administration
measure: Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
timeFrame: 48 hours after drug administration
measure: Adverse events
timeFrame: up to 180 hours after the drug administration
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Elena Neri, MD
role: STUDY_DIRECTOR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Giorgio Cozzi, MD
role: PRINCIPAL_INVESTIGATOR
References: