Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma

  • STATUS
    Recruiting
  • days left to enroll
    45
  • participants needed
    250
  • sponsor
    IRCCS Burlo Garofolo
Updated on 23 January 2021

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)

Details
Condition Acute Pain Due to Trauma
Treatment ketorolac, ibuprofen
Clinical Study IdentifierNCT04133623
SponsorIRCCS Burlo Garofolo
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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