Comparison of Ketorolac at Three Doses in Children With Acute Pain

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective different doses of a pain medication called Ketorolac are for treating acute pain in children aged 6 to 17. Acute pain can happen in situations like appendicitis, migraines, or other urgent medical issues. The researchers want to find out if giving a smaller dose of Ketorolac can relieve pain just as well as a standard higher dose. This is important because using lower doses may reduce the chance of side effects, making the medication safer for children.

To participate, children must be experiencing moderate to severe pain and will be receiving an intravenous (IV) line for treatment. Parents and children who agree to take part in the study will be randomly assigned to receive either the usual dose of Ketorolac or a lower dose, without knowing which one they are getting. Over the next two hours, the research team will ask the child about their pain levels and gather information on how quickly their pain improves and if they need extra medicine. This study aims to improve pain management for children in emergency situations, benefiting not just those at McMaster Children's Hospital, but potentially children worldwide.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 6.0 years to \<18 years: primary outcome measure, 11-point vNRS is validated for use in children ≥6 years, and no other evidence-based acute pain measure is recommended for use in younger children Currently experiencing moderate to severe pain (self-reported pain score \>4 using the vNRS at the time of enrollment; ketorolac is used to treat moderate to severe pain)
• • 2. Patients seen in the ED or inpatient setting with acute pain ≤30 days in duration
• • 3. Patient with IV cannula in situ or ordered (to minimize any additional pain or distress)
• Exclusion Criteria:
• • 1. Previous enrollment in trial (to ensure all observations are independent and not paired)
• • 2. Post-operative patient (as this included medically induced pain, versus pathology-only)
• • 3. Ketorolac 6 hours and/or opioids 4 hours prior to recruitment (avoid over-dosing and confounding)
• • 4. Use of daily analgesic for any indications (confounding as response to analgesics maybe altered)
• • 5. Caregiver and/or child cognitive impairment (precludes the ability to respond to study questions)
• • 6. History of gastrointestinal bleed or ulcers, inflammatory bowel disease, coagulation disorders, cerebrovascular bleeding, known arterio-vascular malformations (increased bleeding risk)
• • 7. History of chronic and active renal disease, excluding renal calculi and urinary tract infections
• • 8. History of chronic and active hepatocellular disease (ketorolac is metabolized in the liver)
• • 9. Known pregnancy at the time of enrollment (risk of closure of patent ductus arteriosus in fetus)
• • 10. Known hypersensitivity to NSAIDs or opioids
• • 11. Inability to obtain consent (language barrier and the absence of language translator)