Comparing different doses of Ketorolac for treating acute pain in children
Comparison of Ketorolac at Three Doses in Children With Acute Pain: A Randomized Controlled Trial
This study tests whether different doses of Ketorolac can help children aged 6 to 17 with moderate to severe pain feel better, while also looking to see if a lower dose works just as well as a higher one.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 171 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT05641363 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of three different doses of Ketorolac in children aged 6 to 17 years who are experiencing moderate to severe acute pain. The study aims to determine if a lower dose of Ketorolac can provide similar pain relief compared to the currently recommended higher doses, thereby minimizing potential side effects. Participants will be randomly assigned to receive one of the doses while their pain levels are monitored using a validated pain scale. The trial is conducted in emergency and inpatient settings to ensure a relevant patient population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 years who are currently experiencing moderate to severe acute pain.
Not a fit: Patients who have recently received other analgesics or are post-operative may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer pain management options for children, reducing reliance on higher doses of medications.
How similar studies have performed: Previous studies in adults have shown that lower doses of Ketorolac can be effective, suggesting potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hamilton, Ontario and 1 other locations
- McMaster University Medical Centre — Hamilton, Ontario, Canada (Recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
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.