Sublingual Analgesia for Acute Abdominal Pain in Children

NCT02465255 | Completed Phase 3

• 1 other identifier: RC 22/13
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Keywords

Acute Abdominal Pain; Sublingual Analgesia; Children; Ketorolac; Tramadol; Paracetamol; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Score

  30 minutes after drug administration

• Pain Score

  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

  up to 180 hours after the drug administration

Study Arms (3)

Ketorolac

EXPERIMENTAL

Ketorolac 0.5 mg/kg administrated by sublingual route

Drug: Ketorolac

Tramadol

ACTIVE COMPARATOR

Tramadol 2.0 mg/kg administrated by sublingual route

Drug: Tramadol

Acetaminophen (paracetamol)

ACTIVE COMPARATOR

Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route

Drug: Acetaminophen

Interventions

Ketorolac DRUG

Ketorolac

Tramadol DRUG

Tramadol

Acetaminophen DRUG

Acetaminophen (paracetamol)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

MeSH Terms

Conditions

Abdominal Pain; Abdomen, Acute; Agnosia

Interventions

Ketorolac; Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Elena Neri, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

• Giorgio Cozzi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

IT (1)