Study of the Efficacy of Kalinox® 170 Bar in Adult Oncology

Study Overview
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Brief Summary
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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.

Official Title
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International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
* Drug: 50% Oxygen/50% Nitrogen premix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) | Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)<br>* gas flow between 4 to 15 L/min<br>|
| Placebo Comparator: B<br>50% oxygen/50% Nitrogen premix | Drug: 50% Oxygen/50% Nitrogen premix<br>* gas flow between 4 to 15 L/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain measurement with visual analogue scale |  | EVA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the kalinox 170 bar in invasives gestures in oncology |  | opinion of the patent and the caregiver | 
| surveillance of the appearance of secondary effects |  | examination by the investigator | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient in a oncology unit who has to undergo a painful or invasive procedure