Status:
COMPLETED
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Acute Pain Due to Trauma
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
Brief 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 litt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04133623
Start Date
November 19 2019
End Date
September 30 2021
Last Update
January 6 2022
Active Locations (3)
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1
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone, Italy
2
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Italy, 34137
3
Ospedale Santa Maria della Misericordia
Udine, Italy