Pain, PostoperativePhase 4DoseRespKetaNCT02994173
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients
A Phase 4 study testing Oxycodone, S-Ketamine 0.25 and S-Ketamine 0.5 in people with Pain, Postoperative, run by Turku University Hospital at 1 site in Finland.
Trial summary
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oxycodone, S-Ketamine 0.25 and S-Ketamine 0.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2017to 5 Dec 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 - 75 years of age
- Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- Written informed consent from the participating patient
Who cannot join
- A previous history of intolerance to the study drug or related compounds and additives
- Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
- Patients younger than 20 years and older than 75 years.
- BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
- Existing significant liver or kidney disease
- History of ischemic heart disease or conduction disturbance
- History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
- Donation of blood for 4 weeks prior and during the study.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, 20521
About this study
Official title: Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
- Conditions
- Pain, Postoperative
- Being tested
- Oxycodone, S-Ketamine 0.25, S-Ketamine 0.5, S-Ketamine 0.75
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxanest
Current clinical practice, used as a control in this study
S-Ketamine 0.25Drug
Also called Ketanest-S
dosage
S-Ketamine 0.5Drug
Also called Ketanest-S
dosage
S-Ketamine 0.75Drug
Also called Ketanest-S
dosage
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Oxycodone 1 mg / ml alone Receives: Drug: Oxycodone |
| Ketamine 0.25 | Active comparator | Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25) Receives: Drug: S-Ketamine 0.25 |
| Ketamine 0.5 | Active comparator | Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5) Receives: Drug: S-Ketamine 0.5 |
| Ketamine 0.75 | Active comparator | Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75) Receives: Drug: S-Ketamine 0.75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
Measured: 24 and 72 hours
Secondary outcomes (1)
Change in numerical rating scale (NRS 0-10)
Change from baseline NRS value postoperatively at 24 and 72 hours
Measured: 24 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion3 Nov 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Turku 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Marko Peltoniemi, MD, PhD, Principal investigator, Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994173
- Sponsor's protocol ID
- T281/2016
- Acronym
- DoseRespKeta
- Status last verified
- Dec 2019
- First submitted
- 3 Nov 2016
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
- ClinicalTrials.gov ID
- NCT02994173
- Acronym / sponsor ID
- DoseRespKeta / T281/2016
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, University of Helsinki
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 15 Dec 2016 (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.
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Drug: OxycodoneOxycodone 1 mg / ml alone |
| Ketamine 0.25 | Active comparator | Drug: S-Ketamine 0.25Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25) |
| Ketamine 0.5 | Active comparator | Drug: S-Ketamine 0.5Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5) |
| Ketamine 0.75 | Active comparator | Drug: S-Ketamine 0.75Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 - 75 years of age
- Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- Written informed consent from the participating patient
Key exclusion criteria (8 listed)
- A previous history of intolerance to the study drug or related compounds and additives
- Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
- Patients younger than 20 years and older than 75 years.
- BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
- Existing significant liver or kidney disease
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 |
|---|---|---|
| OxycodoneAlso: OxanestCurrent clinical practice, used as a control in this study | Drug | Placebo |
| S-Ketamine 0.25Also: Ketanest-Sdosage | Drug | Ketamine 0.25 |
| S-Ketamine 0.5Also: Ketanest-Sdosage | Drug | Ketamine 0.5 |
| S-Ketamine 0.75Also: Ketanest-Sdosage | Drug | Ketamine 0.75 |
Primary outcome
Change in opioid consumption (mg) postoperatively
Time frame: 24 and 72 hours
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
1 secondary outcome
Change in numerical rating scale (NRS 0-10)
Time frame: 24 and 72 hours
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 11 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Marko Peltoniemi, MD, PhD principal investigator
Perioperative Services, Intensive Care and Pain Therapy, Turku 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 Oxycodone, S-Ketamine 0.25 and S-Ketamine 0.5 in people with Pain, Postoperative, run by Turku University Hospital at 1 site in Finland.
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 8 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 11 Dec 2019. 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 Finland. 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?
Change in opioid consumption (mg) postoperatively (time frame: 24 and 72 hours). 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 11 Dec 2019.