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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | Ketorolac 0.5 mg/kg administrated by sublingual route |
|
| Tramadol | Active Comparator | Tramadol 2.0 mg/kg administrated by sublingual route |
|
| Acetaminophen (paracetamol) | Active Comparator | Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug |
| ||
| Tramadol |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia | 34137 | Italy |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D000006 | Abdomen, Acute |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Acetaminophen | Drug |
|
| 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 |
| D012817 | Signs and Symptoms, Digestive |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |