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Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

Study acronym: KETOAPP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of May 14, 2024 to May 27, 2024v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2024 to May 14, 2024
    • Study sites: 0 to 1
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 are other options to treat children's pain that are just as good as opioids, with less side effects. The goal of our study is to discover if school aged children who arrive at the emergency department with belly pain, improve just as much with ketorolac as they do with morphine. To answer this question, we will need a very large number of patients in a study that includes several hospitals across Canada. With a flip of a coin, each participant will either get a single dose of morphine or a single dose of ketorolac. To make sure that our pain assessment is impartial, no one will know which medicine the child received except the pharmacist who prepared the medicine.
Trial Details
NCT Number NCT06160778
Lead Sponsor University of Calgary
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)
Acute Pain, Abdomen, Acute, Abdominal Pain, Appendicitis, Emergencies, Child, Only
Related terms Abdomen, Acute, Abdominal Pain, Acute Pain, Appendicitis, Emergencies
Enrollment 495 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov