Comparing Ketorolac and Morphine for Pain Relief in Children with Appendicitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.