Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma (IbuKet)
Primary Purpose
Acute Pain Due to Trauma
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ketorolac
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring osteoarticular acute pain, ketorolac, 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
Sites / Locations
- Azienda Ospedaliera Santa Maria degli Angeli
- Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
- Ospedale Santa Maria della Misericordia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketorolac
Ibuprofen
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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).
Emergency department outcome
Number of children that, following the emergency department visit, are:
discharged at home
temporary observed in the emergency department
hospitalized
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04133623
Brief Title
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
Acronym
IbuKet
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Due to Trauma
Keywords
osteoarticular acute pain, ketorolac, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double dummy
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
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.
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
Description
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
Secondary Outcome Measure Information:
Title
NRS 30 minutes after the administration of the drug
Description
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
Title
NRS at time 90 minutes after the administration of the drug
Description
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
Title
NRS at time 120 minutes after the administration of the drug
Description
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
Title
Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug.
Description
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
Title
Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug
Description
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.
Title
Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug.
Description
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
Title
Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug.
Description
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.
Title
Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug.
Description
30 minutes after the administration of the drug.
Time Frame
NRS scale will be asked after 30 minutes from the administration of the drug.
Title
Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from the administration of the drug.
Description
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.
Title
Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug.
Description
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.
Title
Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug
Description
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.
Title
Adverse effects in the two groups
Description
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
Title
Emergency department outcome
Description
Number of children that, following the emergency department visit, are:
discharged at home
temporary observed in the emergency department
hospitalized
Time Frame
within 120 minutes from the administration of the drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbi Egidio, MD PhD
Organizational Affiliation
Institute for Maternal and Child Health IRCCS Burlo Garofol
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Ospedaliera Santa Maria degli Angeli
City
Pordenone
Country
Italy
Facility Name
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Facility Name
Ospedale Santa Maria della Misericordia
City
Udine
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
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