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

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 Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 286
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54 500
    • Centre Alexis Vautrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)	Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar); gas flow between 4 to 15 L/min
Placebo Comparator: B; 50% oxygen/50% Nitrogen premix	Drug: 50% Oxygen/50% Nitrogen premix; gas flow between 4 to 15 L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain measurement with visual analogue scale	EVA

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Air Liquide Santé International

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): January 12, 2009
• Last Update Submitted That Met QC Criteria: January 9, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Patient in a oncology unit who has to undergo a painful or invasive procedure
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 2006-003226-29