Comparing Ketorolac and Morphine for Pain Relief in Children with Appendicitis
Intravenous Ketorolac Vs. Morphine In Children Presenting With Acute Abdominal Pain And/or Suspected Appendicitis: A Multi-centre Non-Inferiority Randomized Controlled Trial
This study is testing if ketorolac can help relieve pain just as well as morphine in children aged 6-17 who might have appendicitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 495 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06160778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intravenous ketorolac compared to morphine in reducing pain in children aged 6-17 years with suspected appendicitis. The study will involve a randomized quadruple-blind design across four pediatric emergency departments in Canada, where eligible participants will receive either ketorolac or a placebo while their pain levels are monitored. The primary goal is to determine if ketorolac is as effective as morphine in managing pain, while also assessing the safety profile of both medications. This research addresses the need for safer pain management alternatives amid the ongoing opioid crisis.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-17 years experiencing moderate to severe abdominal pain for up to five days, suspected of having appendicitis.
Not a fit: Patients who are hemodynamically unstable or require immediate resuscitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer, effective alternative to opioids for managing acute abdominal pain in children.
How similar studies have performed: Previous studies have shown promising results for ketorolac in adult populations, but this specific approach in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 6 to 17 years 2. Abdominal pain ≤5 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 ≥5 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.
Where this trial is running
Calgary, Alberta
- Alberta Children's Hospital Emergency Department — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Mohamed Eltorki, MBChB — University of Calgary
- Study coordinator: Mohamed M Eltorki, MBChB, MSc
- Email: mmeltork@ucalgary.ca
- Phone: +1403-955-7723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.