Status:
RECRUITING
Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Acute Pain
Abdomen, Acute
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
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 n...
Detailed Description
Background: Appendicitis, the most common surgical diagnosis in Canadian children aged 6-17 years, accounts for \~8000 admissions annually. Despite an ongoing opioid crisis, prescription narcotics rem...
Eligibility Criteria
Inclusion
- Age 6 to 17 years
- Abdominal pain ≤5 days duration
- Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis
- Patient with IV cannula in situ or ordered
- Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale
Exclusion
- Previous enrollment in the trial
- 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).
- Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1
- Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions.
- Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered.
- 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.
- History of chronic and active interstitial kidney disease
- History of chronic and active hepatocellular disease: ketorolac is metabolized by the liver.
- Known or suspected pregnancy at the time of enrollment or breastfeeding females
- Known hypersensitivity to NSAIDs or opioids.
- Absence of a parent/guardian for children who are \<16 years of age if they are not a mature minor.
- 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.
Key Trial Info
Start Date :
May 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT06160778
Start Date
May 27 2024
End Date
December 1 2029
Last Update
June 24 2024
Active Locations (1)
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1
Alberta Children's Hospital Emergency Department
Calgary, Alberta, Canada, T3B 6A8