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

Phase 4

Completed

• Conditions: Cancer; Pain
• Interventions: Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar); Drug: 50% Oxygen/50% Nitrogen premix

• Registration Number: NCT00646945
• Lead Sponsor: Air Liquide Santé International

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)	50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
B	50% Oxygen/50% Nitrogen premix	50% oxygen/50% Nitrogen premix

Primary Outcome Measures

Name	Time	Method
pain measurement with visual analogue scale	EVA

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre les nancy, France