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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646945
First Posted: March 31, 2008
Last Update Posted: January 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Air Liquide Santé International
  Purpose
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.

Condition Intervention Phase
Cancer Pain Drug: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) Drug: 50% Oxygen/50% Nitrogen premix Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • pain measurement with visual analogue scale [ Time Frame: EVA ]

Secondary Outcome Measures:
  • feasibility of the kalinox 170 bar in invasives gestures in oncology [ Time Frame: opinion of the patent and the caregiver ]
  • surveillance of the appearance of secondary effects [ Time Frame: examination by the investigator ]

Estimated Enrollment: 286
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646945


Locations
France
Centre Alexis Vautrin
Vandoeuvre les nancy, France, 54 500
Sponsors and Collaborators
Air Liquide Santé International
  More Information

Responsible Party: peter Onody / PHD and director of medico-marketing department, Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT00646945     History of Changes
Other Study ID Numbers: 2006-003226-29
First Submitted: March 20, 2008
First Posted: March 31, 2008
Last Update Posted: January 12, 2009
Last Verified: January 2009

Keywords provided by Air Liquide Santé International:
Patient in a oncology unit who has to undergo a painful or invasive procedure

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents