NCT00646945

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Pain

Interventions

Type	Name	Description
DRUG	50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)	gas flow between 4 to 15 L/min
DRUG	50% Oxygen/50% Nitrogen premix	gas flow between 4 to 15 L/min

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-03-31
• Last updated: 2025-09-16

Locations

1 site across 1 country: France