Knee InjuriesPhase 4Knemikro01NCT00774540
Acute Pain and Inflammation After Surgery
A Phase 4 study testing 1 Ketorolac intraarticular in people with Knee Injuries, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is 1. to observe acute pain after surgery and measure the natural course of inflammatory mediators 2. study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- 1 Ketorolac intraarticular
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2008to Dec 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Day case surgical patients above 18 years old
- Non pregnant
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Division of Emergencies and Critical Care
Oslo, 0242
About this study
Official title: Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis
The purpose of this study is
- to observe acute pain after surgery and measure the natural course of inflammatory mediators
- study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac
Read the detailed description
Randomizized controlled trial
- Conditions
- Knee Injuries
- Being tested
- 1 Ketorolac intraarticular, Placebo
- Keywords
- Acute pain, Inflammatory pain, Inflammatory mediators, Pain relief, Microdialysis
- Medical subject headings
- Knee Injuries, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Ketorolac intraarticularDrug
Also called Ketorolac, Saline
Ketorolac intraarticular 5 mg
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ketorolac Receives: Drug: 1 Ketorolac intraarticular |
| 2 | Placebo comparator | saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief local anti-flammatory effects
Measured: 2 h
Secondary outcomes (1)
Rescue analgesic consumption
Measured: 2 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
- Investigators
- Leiv Arne Rosseland, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774540
- Sponsor's protocol ID
- Knemikro01
- Other IDs
- S-04342
- Acronym
- Knemikro01
- Status last verified
- Apr 2015
- First submitted
- 16 Oct 2008
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis
- ClinicalTrials.gov ID
- NCT00774540
- Acronym / sponsor ID
- Knemikro01 / Knemikro01
- Conditions
- Knee Injuries
- Keywords
- Acute pain, Inflammatory pain, Inflammatory mediators, Pain relief, Microdialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2008 (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.
The purpose of this study is
- to observe acute pain after surgery and measure the natural course of inflammatory mediators
- study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac
Detailed description
Randomizized controlled trial
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 | Experimental | Drug: 1 Ketorolac intraarticularKetorolac |
| 2 | Placebo comparator | Drug: Placebosaline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Day case surgical patients above 18 years old
- Non pregnant
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 1 Ketorolac intraarticularAlso: Ketorolac, SalineKetorolac intraarticular 5 mg | Drug | 1 |
| PlaceboSaline | Drug | 2 |
Primary outcome
Pain relief local anti-flammatory effects
Time frame: 2 h
1 secondary outcome
Rescue analgesic consumption
Time frame: 2 h
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 23 Apr 2015.
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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.
Leiv Arne Rosseland principal investigator
Oslo University Hospital
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 1 Ketorolac intraarticular in people with Knee Injuries, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 1 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 23 Apr 2015. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Pain relief local anti-flammatory effects (time frame: 2 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2015.