CancerPhase 4NCT00646945
Study of the Efficacy of Kalinox® 170 Bar in Adult Oncology
A Phase 4 study testing 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) and 50% Oxygen/50% Nitrogen premix in people with Cancer and Pain, run by Air Liquide Santé International at 1 site in France.
Trial summary
In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) and 50% Oxygen/50% Nitrogen premix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 year
- OMS between 0 to 3
- Patient who has to undergo an invasive gesture or a painful care
- Absence of contra-indication to the administration of the product
Who cannot join
- Patient already included in another incompatible study with this protocol
- Patient incapable of self-assessment by the EVA
- Confusional syndrome
- OMS > 3
- Patient already included in this protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.
- Being tested
- 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar), 50% Oxygen/50% Nitrogen premix
- Keywords
- Patient in a oncology unit who has to undergo a painful or invasive procedure
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)Drug
gas flow between 4 to 15 L/min
50% Oxygen/50% Nitrogen premixDrug
gas flow between 4 to 15 L/min
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) Receives: Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) |
| B | Placebo comparator | 50% oxygen/50% Nitrogen premix Receives: Drug: 50% Oxygen/50% Nitrogen premix |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain measurement with visual analogue scale
Measured: EVA
Secondary outcomes (2)
feasibility of the kalinox 170 bar in invasives gestures in oncology
Measured: opinion of the patent and the caregiver
surveillance of the appearance of secondary effects
Measured: examination by the investigator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionOct 2008
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 CancerStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646945
- Sponsor's protocol ID
- 2006-003226-29
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2008
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Prise en charge de la douleur au cours des procédures invasives en cancérologie : efficacité et acceptabilité du mélange inhalé 50 % N2O/O2 (MEOPA) Pain management during invasive procedures in oncology: inhaled 50% N2O/O2 premix, an effective and well tolerated method I. Krakowski · D Baylot · G. Chvetzoff · E. Collin · R. Coulouma · F. Dixmerias · L. Feuvret · C. Freyssinet-Durand · E. Lauwers-Allot · D. Lossignol · C. Billoët Douleur analg. (2010) 23:113-120 DOI 10.1007/s11724-010-0197-5
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
- ClinicalTrials.gov ID
- NCT00646945
- Acronym / sponsor ID
- 2006-003226-29
- Keywords
- Patient in a oncology unit who has to undergo a painful or invasive procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Mar 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.
In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) |
| B | Placebo comparator | Drug: 50% Oxygen/50% Nitrogen premix50% oxygen/50% Nitrogen premix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 year
- OMS between 0 to 3
- Patient who has to undergo an invasive gesture or a painful care
- Absence of contra-indication to the administration of the product
Key exclusion criteria (5 listed)
- Patient already included in another incompatible study with this protocol
- Patient incapable of self-assessment by the EVA
- Confusional syndrome
- OMS > 3
- Patient already included in this protocol
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 |
|---|---|---|
| 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)gas flow between 4 to 15 L/min | Drug | A |
| 50% Oxygen/50% Nitrogen premixgas flow between 4 to 15 L/min | Drug | B |
Primary outcome
pain measurement with visual analogue scale
Time frame: EVA
2 secondary outcomes
feasibility of the kalinox 170 bar in invasives gestures in oncology
Time frame: opinion of the patent and the caregiver
surveillance of the appearance of secondary effects
Time frame: examination by the investigator
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 16 Sep 2025.
- Results publicationPrise en charge de la douleur au cours des procédures invasives en cancérologie : efficacité et acceptabilité du mélange inhalé 50 % N2O/O2 (MEOPA) Pain management during invasive procedures in oncology: inhaled 50% N2O/O2 premix, an effective and well tolerated method I. Krakowski · D Baylot · G. Chvetzoff · E. Collin · R. Coulouma · F. Dixmerias · L. Feuvret · C. Freyssinet-Durand · E. Lauwers-Allot · D. Lossignol · C. Billoët Douleur analg. (2010) 23:113-120 DOI 10.1007/s11724-010-0197-5
- Related InfoLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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?
A Phase 4 study testing 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) and 50% Oxygen/50% Nitrogen premix in people with Cancer and Pain, run by Air Liquide Santé International at 1 site in France.
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 4 inclusion and 5 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 16 Sep 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 France. 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 measurement with visual analogue scale (time frame: EVA). 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 NCT00646945, 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 16 Sep 2025.