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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646945

Enrollment

204

Registered

2008-03-31

Start date

2007-09-30

Completion date

2008-10-31

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pain

Keywords

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

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.

Interventions

DRUG50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)

gas flow between 4 to 15 L/min

DRUG50% Oxygen/50% Nitrogen premix

gas flow between 4 to 15 L/min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 *

Design outcomes

Primary

Measure	Time frame
pain measurement with visual analogue scale	EVA

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026