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โ† Trials
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Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

RecruitingPhase 3Ages 6 Years - 17 YearsAllUniversity of Calgary
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In plain words

What the trial is, and whether it could suit you

Appendicitis is a common condition in children 6-17 years of age, and the top reason for emergency surgery in Canada. Children with appendicitis can have very bad pain in their belly. Children often need pain medications given to them through a needle in their arm called an intravenous (IV). The most common IV pain medication is a type of opioid called morphine. We know that opioids work well to improve pain, but there are risks and side effects when taking them. There are non-opioid medications that doctors can give to patients, like ketorolac. Ketorolac helps decrease inflammation and pain and has fewer side effects when a patient takes it for a short period of time. Our past and present overuse of opioids, driven by an unproven assumption that opioids work best for pain, resulted in an Opioid Crisis and doctors are now looking for alternatives. To do this, we need to prove that there

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 6 to 17 years 2. Abdominal pain โ‰ค5 days duration 3. Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis 4. Patient with IV cannula in situ or ordered 5. Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score โ‰ฅ5 using the verbal Numerical Rating Scale Exclusion Criteria: 1. Previous enrollment in the trial 2. NSAID use within 3 hours and/or opioid use within 1 to 2 hours (1 hour post-IV or intra-nasal fentanyl and 2 hours post IV morphine). 3. Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1 4. Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions. 5. Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered. 6. History of severe undiagnosed gastrointestinal bleeding requiring medical intervention, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations. History of minor gastrointestinal bleeding from conditions such as resolved fissures, polyps or allergic colitis will not exclude patients from participating. 7. History of chronic and active interstitial kidney disease 8. History of chronic and active hepatocellular disease: ketorolac is metabolized by the liver. 9. Known or suspected pregnancy at the time of enrollment or breastfeeding females 10. Known hypersensitivity to NSAIDs or opioids. 11. Absence of a parent/guardian for children who are \<16 years of age if they are not a mature minor. 12. Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED.
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What it tests

  • Ketorolac Tromethamine
  • Morphine Sulfate
  • normal saline
  • Normal saline
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Where

1 site
Alberta Children's Hospital Emergency Department
Calgary, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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