Skip to main content
OpenTrials
Completed

NCT Number: NCT02465255

Sublingual Analgesia for Acute Abdominal Pain in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Pain Abdomen, Acute Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

Tramadol

Drug

Acetaminophen

Drug

Primary outcomes

  1. Pain Score

    Time frame: 120 minutes after drug administration

    Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age

Secondary outcomes

  1. Pain Score

    Time frame: 30 minutes after drug administration

    Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age

  2. Pain Score

    Time frame: 60 minutes after drug administration

    Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age

  3. Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)

    Time frame: 24 hours after drug administration

  4. Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)

    Time frame: 48 hours after drug administration

  5. Adverse events

    Time frame: up to 180 hours after the drug administration

    Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.