Chronic PainKONTINUENCT06131970
The Effectiveness of Continuous Ketamine Infusion (KONTINUE)
An observational study of Chronic Pain, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 80 participants
- Where
- 1 siteMonaco
- Study dates
- 22 Feb 2022to 6 Aug 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pain treated with ketamine infusion
Who may be able to join
- Pain lasting for more than six months without contraindication to treatment
Who cannot join
- Inability to give consent
- Severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study
There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.
Read the detailed description
Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day.
Evaluation schedules will be performed at day 15,30 and 60.
- Conditions
- Chronic Pain
- Keywords
- Pain, Neuropathic pain, Chronic pain, Fibromyalgia, Musculoskeletal diseases
- Medical subject headings
- Chronic Pain, Pain, Neuralgia, Fibromyalgia, Musculoskeletal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term effectiveness
Improvement of the numerical scale - score 0 to 10 - 10 is the worst
Measured: 1 month
Long-term effectiveness
Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst
Measured: 1 month
Secondary outcomes (3)
Pain relief
Neuropathic Pain Symptom Inventory (NPSI) - score 0 to 10 - 10 is the worst
Measured: 15, 30, 60 days
Variation of quality of life
Short Form 12 health survey
Measured: 15, 30, 60 days
Variation of quality of life
Hospital Anxiety and Depression scale - score 0 to 21 - 21 is the worst
Measured: 15, 30, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Feb 2022
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131970
- Sponsor's protocol ID
- 21-12
- Acronym
- KONTINUE
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06131970
- Acronym / sponsor ID
- KONTINUE / 21-12
- Conditions
- Chronic Pain
- Keywords
- Pain, Neuropathic pain, Chronic pain, Fibromyalgia, Musculoskeletal diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 15 Nov 2023 (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.
There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.
Detailed description
Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day.
Evaluation schedules will be performed at day 15,30 and 60.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain treated with ketamine infusion
Key inclusion criteria (1 listed)
- Pain lasting for more than six months without contraindication to treatment
Key exclusion criteria (2 listed)
- Inability to give consent
- Severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term effectiveness
Time frame: 1 month
Improvement of the numerical scale - score 0 to 10 - 10 is the worst
Long-term effectiveness
Time frame: 1 month
Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst
3 secondary outcomes
Pain relief
Time frame: 15, 30, 60 days
Variation of quality of life
Time frame: 15, 30, 60 days
Variation of quality of life
Time frame: 15, 30, 60 days
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 19 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 2 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 19 Feb 2025. 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 Monaco. 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.
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?
Long-term effectiveness (time frame: 1 month). The study lists 2 primary outcomes in all. 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 19 Feb 2025.