Acute Pain Due to TraumaPhase 3IbuKetNCT04133623
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
A Phase 3 study testing Ketorolac and Ibuprofen in people with Acute Pain Due to Trauma, run by IRCCS Burlo Garofolo at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Acute Pain Due to Trauma
- What is being tested?
- Ketorolac and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesItaly
- Study dates
- 19 Nov 2019to 30 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, 34137
Ospedale Santa Maria della Misericordia
Udine
About this study
Official title: Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.
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.
Read more
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)
- Conditions
- Acute Pain Due to Trauma
- Keywords
- osteoarticular acute pain, ketorolac, ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
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.
IbuprofenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketorolac |
| 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. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes after the administration of the drug
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: within 120 minutes from the administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start19 Nov 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pain Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbi Egidio, MD PhD, Study chair, Institute for Maternal and Child Health IRCCS Burlo Garofol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133623
- Sponsor's protocol ID
- RC 21/18
- Acronym
- IbuKet
- Status last verified
- Jan 2022
- First submitted
- 18 Oct 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36526794
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.
- ClinicalTrials.gov ID
- NCT04133623
- Acronym / sponsor ID
- IbuKet / RC 21/18
- Conditions
- Acute Pain Due to Trauma
- Keywords
- osteoarticular acute pain, ketorolac, ibuprofen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: KetorolacAdministration 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 | Drug: IbuprofenAdministration 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAdministration 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 |
| IbuprofenAdministration 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 |
Primary outcome
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
Time frame: 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.
13 secondary outcomes
NRS 30 minutes after the administration of the drug
Time frame: 30 minutes after the administration of the drug
NRS at time 90 minutes after the administration of the drug
Time frame: 90 minutes after the administration of the drug
NRS at time 120 minutes after the administration of the drug
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.
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
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.
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.
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.
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.
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.
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
Time frame: 120 minutes after the administration of the drug.
Adverse effects in the two groups
Time frame: within 120 minutes from the administration of the drug
Emergency department outcome
Time frame: within 120 minutes from the administration of the drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 36526794Ghirardo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbi Egidio, MD PhD study chair
Institute for Maternal and Child Health IRCCS Burlo Garofol
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac and Ibuprofen in people with Acute Pain Due to Trauma, run by IRCCS Burlo Garofolo at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug (time frame: 60 minutes after the administration of the drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.