Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
NCT06160778

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

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Alberta Children's Hospital Emergency Department

Calgary, Alberta, Canada, T3B 6A8

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here