Actively Recruiting
Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
Led by University of Calgary · Updated on 2024-06-24
495
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 17 years
- Abdominal pain lasting 5 days or less
- Acute abdominal pain being investigated for suspected appendicitis
- Presence of intravenous (IV) access or planned IV insertion
- Moderate to severe abdominal pain with a self-reported score of 5 or higher on the verbal Numerical Rating Scale
You will not qualify if you...
- Previous participation in this trial
- Use of NSAIDs within 3 hours or opioids within 1 to 2 hours prior to enrollment
- Need for immediate resuscitation or hemodynamic instability
- Canadian Triage Assessment Score of 1
- Significant cognitive impairment in child or caregiver preventing study participation
- Chronic pain requiring daily pain medication
- History of severe gastrointestinal bleeding, ulcers, inflammatory bowel disease, coagulation disorders, cerebrovascular bleeding, or vascular malformations
- History of chronic active kidney or liver disease
- Known or suspected pregnancy or breastfeeding in females
- Known allergy to NSAIDs or opioids
- Lack of parent/guardian for children under 16 years if not a mature minor
- Inability to consent due to language barrier without available translation services
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alberta Children's Hospital Emergency Department
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
Research Team
M
Mohamed M Eltorki, MBChB, MSc
CONTACT
A
Angela Wallace
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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