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Completed

NCT Number: NCT00646945

Study of the Efficacy of Kalinox® 170 Bar 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.

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Key information

Conditions

Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54 500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

gas flow between 4 to 15 L/min

50% Oxygen/50% Nitrogen premix

Drug

gas flow between 4 to 15 L/min

Primary outcomes

  1. pain measurement with visual analogue scale

    Time frame: EVA

Secondary outcomes

  1. feasibility of the kalinox 170 bar in invasives gestures in oncology

    Time frame: opinion of the patent and the caregiver

  2. surveillance of the appearance of secondary effects

    Time frame: examination by the investigator

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 31, 2008
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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