Sublingual Analgesia for Acute Abdominal Pain in Children

Phase 3

Completed

• Conditions: Abdominal Pain
• Interventions: Drug: Ketorolac; Drug: Tramadol; Drug: Acetaminophen

• Registration Number: NCT02465255
• Lead Sponsor: IRCCS Burlo Garofolo

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 Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	Ketorolac 0.5 mg/kg administrated by sublingual route
Tramadol	Tramadol	Tramadol 2.0 mg/kg administrated by sublingual route
Acetaminophen (paracetamol)	Acetaminophen	Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route

Primary Outcome Measures

Name	Time	Method
Pain Score	120 minutes after drug administration	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age

Secondary Outcome Measures

Name	Time	Method
Pain Score	60 minutes after drug administration	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Adverse events	up to 180 hours after the drug administration	Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)	48 hours after drug administration

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy