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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
212
Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.
Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone, Italy
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Italy
Ospedale Santa Maria della Misericordia
Udine, Italy
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
NRS scale will be asked after 60 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment. The difference will be calculated from the baseline.
Time frame: 60 minutes after the administration of the drug
NRS 30 minutes after the administration of the drug
NRS scale will be asked after 30 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 30 minutes after the administration of the drug
NRS at time 90 minutes after the administration of the drug
NRS scale will be asked after 90 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 90 minutes after the administration of the drug
NRS at time 120 minutes after the administration of the drug
NRS scale will be asked after 120 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 120 minutes after the administration of the drug
Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug.
NRS scale will be asked after 30 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 30 minutes after the administration of the drug
Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug
NRS scale will be asked after 60 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 60 minutes after the administration of the drug.
Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug.
NRS scale will be asked after 90 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 90 minutes after the administration of the drug
Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug.
NRS scale will be asked after 120 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 120 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug.
30 minutes after the administration of the drug.
Time frame: NRS scale will be asked after 30 minutes from the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from the administration of the drug.
NRS scale will be asked after 60 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment
Time frame: 60 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug.
NRS scale will be asked after 90 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment.
Time frame: 90 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug
NRS scale will be asked after 120 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment
Time frame: 120 minutes after the administration of the drug.
Adverse effects in the two groups
By the medical or nursing staff patients will be evaluated after administration of the drug (headache, nausea, vomiting, somnolence, dyspepsia, abdominal pain, pruritus, dizziness and other reported symptoms).
Time frame: within 120 minutes from the administration of the drug
Emergency department outcome
Number of children that, following the emergency department visit, are: 1. discharged at home 2. temporary observed in the emergency department 3. hospitalized
Time frame: within 120 minutes from the administration of the drug
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