Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

Launched by UNIVERSITY OF CALGARY · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well two different pain medications work for children aged 6 to 17 who come to the emergency department with severe belly pain, often due to a condition called appendicitis. The researchers want to compare the effects of ketorolac, a non-opioid medication that reduces pain and inflammation, with morphine, a common pain relief medication that is an opioid. The goal is to find out if ketorolac can relieve pain just as effectively as morphine, but with fewer side effects.

To participate in the trial, children must be between 6 to 17 years old and have had belly pain for 5 days or less, which the doctors suspect could be appendicitis. They should also be experiencing moderate to severe pain. If eligible, participants will receive either morphine or ketorolac through an IV (a needle in their arm), and no one except the pharmacist will know which medication they received. This study is being conducted in multiple hospitals across Canada, and it's important to help find safer pain management options for kids in the future.

Gender

ALL

Eligibility 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.