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

Study Overview
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Brief Summary
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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: 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)

Official Title
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Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.

Conditions
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Acute Pain Due to Trauma

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>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. | Drug: Ketorolac<br>* 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.<br>|
| Active Comparator: Ibuprofen<br>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. | Drug: Ibuprofen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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: discharged at home temporary observed in the emergency department hospitalized | within 120 minutes from the administration of the drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarticular acute pain, ketorolac, ibuprofen