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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ketorolac; Drug: Tramadol

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac; Ketorolac 0.5 mg/kg administrated by sublingual route	Drug: Ketorolac
Active Comparator: Tramadol; Tramadol 2.0 mg/kg administrated by sublingual route	Drug: Tramadol
Active Comparator: Acetaminophen (paracetamol); Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route	Drug: Acetaminophen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age	30 minutes after drug administration
Pain Score	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age	60 minutes after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)		24 hours after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)		48 hours after drug administration
Adverse events	Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding	up to 180 hours after the drug administration

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Elena Neri, MD, IRCCS Burlo Garofolo, Trieste, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Children; Analgesia; Paracetamol; Ketorolac; Tramadol; Acute Abdominal Pain; Sublingual Analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Abdomen, Acute; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Ketorolac; Acetaminophen; Tramadol
• Other Study ID Numbers: RC 22/13