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

Air Liquide Santé International204 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

204

Conditions

Cancer Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pain measurement with visual analogue scale

Time frame: EVA

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