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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | 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. |
|
| Ibuprofen | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes after the administration of the drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes after the administration of the drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbi Egidio, MD PhD | Institute for Maternal and Child Health IRCCS Burlo Garofol | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Santa Maria degli Angeli | Pordenone | Italy | ||||
| Institute for Maternal and Child Health - IRCCS Burlo Garofolo- |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36526794 | Derived | Ghirardo S, Trevisan M, Ronfani L, Zanon D, Maestro A, Barbieri F, De Nardi L, Amaddeo A, Barbi E, Cozzi G. Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study. Eur J Pediatr. 2023 Feb;182(2):929-935. doi: 10.1007/s00431-022-04759-3. Epub 2022 Dec 17. |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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double dummy
| Ibuprofen | Drug | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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 | 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). | within 120 minutes from the administration of the drug |
| Emergency department outcome | Number of children that, following the emergency department visit, are:
| within 120 minutes from the administration of the drug |
| Trieste |
| 34137 |
| Italy |
| Ospedale Santa Maria della Misericordia | Udine | Italy |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |