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Sublingual Analgesia for Acute Abdominal Pain in Children

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ClinicalTrials.gov Identifier: NCT02465255
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Luca Ronfani, IRCCS Burlo Garofolo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Abdominal Pain Drug: Ketorolac Drug: Tramadol Drug: Acetaminophen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465255


Locations
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Italy
IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Elena Neri, MD IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Giorgio Cozzi, MD IRCCS Burlo Garofolo, Trieste, Italy
More Information
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Responsible Party: Luca Ronfani, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02465255    
Other Study ID Numbers: RC 22/13
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Luca Ronfani, IRCCS Burlo Garofolo:
Acute Abdominal Pain
Sublingual Analgesia
Children
Ketorolac
 Tramadol
Paracetamol
Analgesia
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Acetaminophen
Ketorolac
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants