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

NCT00646945 | Completed Phase 4

• 1 other identifier: 2006-003226-29
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Pain

Keywords

Patient in a oncology unit who has to undergo a painful or invasive procedure

Outcome Measures

Primary Outcomes (1)

• pain measurement with visual analogue scale

  EVA

Secondary Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

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

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

B

PLACEBO COMPARATOR

50% oxygen/50% Nitrogen premix

Drug: 50% Oxygen/50% Nitrogen premix

Interventions

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

gas flow between 4 to 15 L/min

A

50% Oxygen/50% Nitrogen premix DRUG

gas flow between 4 to 15 L/min

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead

Study Sites (1)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54 500, France

Location

Related Publications (1)

• Prise en charge de la douleur au cours des procédures invasives en cancérologie : efficacité et acceptabilité du mélange inhalé 50 % N2O/O2 (MEOPA) Pain management during invasive procedures in oncology: inhaled 50% N2O/O2 premix, an effective and well tolerated method I. Krakowski · D Baylot · G. Chvetzoff · E. Collin · R. Coulouma · F. Dixmerias · L. Feuvret · C. Freyssinet-Durand · E. Lauwers-Allot · D. Lossignol · C. Billoët Douleur analg. (2010) 23:113-120 DOI 10.1007/s11724-010-0197-5

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 31, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)