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

This study has been completed.
Sponsor:
Information provided by:
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT00646945
First received: March 20, 2008
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • pain measurement with visual analogue scale [ Time Frame: EVA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • feasibility of the kalinox 170 bar in invasives gestures in oncology [ Time Frame: opinion of the patent and the caregiver ] [ Designated as safety issue: No ]
  • surveillance of the appearance of secondary effects [ Time Frame: examination by the investigator ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646945

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

No publications provided

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
Study First Received: March 20, 2008
Last Updated: January 9, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 22, 2013