Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma (NCT04133623) | Clinical Trial Compass
CompletedPhase 3
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
Italy212 participantsStarted 2019-11-19
Plain-language summary
Pain is the leading cause of access to the paediatric emergency department (ED) and present in up to 78% of cases.
Acute osteoarticular traumatic pain is often treated inadequately, and there is little data about the best treatment for children. The ibuprofen and ketorolac are respectively the most used and one of the most powerful NSAIDs. In literature, there is no direct comparison between those two medications.
The objective of the study depends on the level of pain:
* in severe traumatic acute pain (\>=7 points): to evaluate if ketorolac is superior to ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to ibuprofen)
* in moderate traumatic acute pain (\<7 points): to evaluate if ibuprofen is not inferior to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60 to ibuprofen)
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 8 and 18 years
* Moderate to severe pain (value\>= 4 on the Numerical Rating scale / NRS)
* Pain due to a trauma at limbs that has occurred in the last 48 hours
Exclusion Criteria:
* Administration of any analgesic in the previous 8 hours.
* Allergy known to one of the active ingredients
* Known hepatopathy or nephropathy
* Suspicion of violence by others
* Chronic use of painkillers
* Inability to report pain due to the presence of: intellectual disability (IQ \<70); moderate-severe hearing loss; communication limitations such as patient mutism; unable to write; inability to speak Italian
* Chronic neurological or metabolic diseases,
* Positive history for ease of bleeding, coagulation disorder or
* thrombocytopenia
* A history of gastritis or esophagitis in the last 30 days
* Multiple trauma
* Vascular-vascular deficit
* State of pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
Timeframe: 60 minutes after the administration of the drug