FracturePhase 4NCT00560443
RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
A Phase 4 study testing ketorolac and tramadol in people with Fracture and Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old: ketorolac 0,5 mg/kg (1 drop every 2 Kg) tramadol 2,5 mg/Kh (1 drop every 2 Kg) Intensity of pain will be estimated with linear 1 to 10 or analogic… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- What is being tested?
- ketorolac and tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Apr 2012
- Phase
- Phase 4
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 4-17 years old with not compound bone fracture presenting in emergency room
Who cannot join
- Compound fracture
- Occurring pain still treated
- Contraindicated ketorolac or tramadol use
- Informed consensus not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:
- ketorolac 0,5 mg/kg (1 drop every 2 Kg)
- tramadol 2,5 mg/Kh (1 drop every 2 Kg)
Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.
The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects
- Being tested
- ketorolac, tramadol
- Keywords
- bone fracture, ketorolac, tramadol
- Medical subject headings
- Fractures, Bone, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolacDrug
0,5 mg/kg per os one time
tramadolDrug
2,5 mg/ kg per os in one dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | children 4-17 y. old with not compound bone fracture treated with ketorolac Receives: Drug: ketorolac |
| 2 | Experimental | children 4-17 y. old with not compound bone fracture treated with tramadol Receives: Drug: tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
Measured: 6 hours (or until the end of procedures)
Secondary outcomes (1)
comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
Measured: 6 hours or until the end of procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionApr 2012
- Study completionApr 2012
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 FractureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edoardo Guglia, md, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560443
- Sponsor's protocol ID
- RC 30/07
- Status last verified
- Aug 2017
- First submitted
- 7 Nov 2007
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.
PubMed 23702435
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
- ClinicalTrials.gov ID
- NCT00560443
- Acronym / sponsor ID
- RC 30/07
- Keywords
- bone fracture, ketorolac, tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Nov 2007 (estimated)
- 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.
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:
- ketorolac 0,5 mg/kg (1 drop every 2 Kg)
- tramadol 2,5 mg/Kh (1 drop every 2 Kg)
Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.
The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ketorolacchildren 4-17 y. old with not compound bone fracture treated with ketorolac |
| 2 | Experimental | Drug: tramadolchildren 4-17 y. old with not compound bone fracture treated with tramadol |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 4-17 years old with not compound bone fracture presenting in emergency room
Key exclusion criteria (4 listed)
- Compound fracture
- Occurring pain still treated
- Contraindicated ketorolac or tramadol use
- Informed consensus not obtained
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 |
|---|---|---|
| ketorolac0,5 mg/kg per os one time | Drug | 1 |
| tramadol2,5 mg/ kg per os in one dose | Drug | 2 |
Primary outcome
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
Time frame: 6 hours (or until the end of procedures)
1 secondary outcome
comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
Time frame: 6 hours or until the end of procedures
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 24 Aug 2017.
- Derived from this study: PubMed 23702435Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.
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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.
Edoardo Guglia, md principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketorolac and tramadol in people with Fracture and Pain, run by IRCCS Burlo Garofolo at 1 site 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 1 inclusion and 4 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale (time frame: 6 hours (or until the end of procedures)). 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 NCT00560443, 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 24 Aug 2017.