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

Air Liquide

Status and phase: Completed; Phase 4

Conditions: Cancer; Pain

Treatments: Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar); Drug: 50% Oxygen/50% Nitrogen premix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646945

2006-003226-29

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

204 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)

Treatment:

Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)

B

Placebo Comparator group

Description:

50% oxygen/50% Nitrogen premix

Treatment:

Drug: 50% Oxygen/50% Nitrogen premix