Sublingual Analgesia for Acute Abdominal Pain in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Tramadol
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Abdominal Pain, Sublingual Analgesia, Children, Ketorolac, Tramadol, Paracetamol, Analgesia