Clinical trial · Interventional
Study of the Efficacy of Kalinox® 170 Bar in Adult Oncology
International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50% Oxygen/50% Nitrogen premix | Drug | — | UNRESOLVED |
| 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
- interventionNames
- Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- 50% oxygen/50% Nitrogen premix
- interventionNames
- Drug: 50% Oxygen/50% Nitrogen premix
Primary outcomes (1)
- measure
- pain measurement with visual analogue scale
- timeFrame
- EVA
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Exclusion criteria linked to the product
References
Publications (1)
- RESULTPrise 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