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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646945
• Other study ID #: 2006-003226-29
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2008
• Last updated: January 9, 2009
• Start date: September 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
gas flow between 4 to 15 L/min
• 50% Oxygen/50% Nitrogen premix
gas flow between 4 to 15 L/min

Locations

Country	Name	City	State
France	Centre Alexis Vautrin	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain measurement with visual analogue scale		EVA	No
Secondary	feasibility of the kalinox 170 bar in invasives gestures in oncology		opinion of the patent and the caregiver	No
Secondary	surveillance of the appearance of secondary effects		examination by the investigator	Yes