Clinical trial NCT04133623: Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
Official title: Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain Due to Trauma
Keywords: osteoarticular acute pain
ketorolac
ibuprofen
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 212
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)


Eligibility criteria: 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

Primary outcomes:
measure: Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
timeFrame: 60 minutes after the administration of the drug
Secondary outcomes:
measure: NRS 30 minutes after the administration of the drug
timeFrame: 30 minutes after the administration of the drug
measure: NRS at time 90 minutes after the administration of the drug
timeFrame: 90 minutes after the administration of the drug
measure: NRS at time 120 minutes after the administration of the drug
timeFrame: 120 minutes after the administration of the drug
measure: Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug.
timeFrame: 30 minutes after the administration of the drug
measure: Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug
timeFrame: 60 minutes after the administration of the drug.
measure: Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug.
timeFrame: 90 minutes after the administration of the drug
measure: Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug.
timeFrame: 120 minutes after the administration of the drug.
measure: Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug.
timeFrame: NRS scale will be asked after 30 minutes from the administration of the drug.
measure: Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from the administration of the drug.
timeFrame: 60 minutes after the administration of the drug.
measure: Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug.
timeFrame: 90 minutes after the administration of the drug.
measure: Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug
timeFrame: 120 minutes after the administration of the drug.
measure: Adverse effects in the two groups
timeFrame: within 120 minutes from the administration of the drug
measure: Emergency department outcome
timeFrame: within 120 minutes from the administration of the drug
Other outcomes:
Locations:
city: Pordenone
country: Italy
facility: Azienda Ospedaliera Santa Maria degli Angeli
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofol
name: Barbi Egidio, MD PhD
role: STUDY_CHAIR
References: