International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Pain
Both
Cancer, Pain
Trial Information
International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
pain measurement with visual analogue scale
Outcome Time Frame:
EVA
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2006-003226-29
NCT ID:
NCT00646945
Start Date:
September 2007
Completion Date:
October 2008
Related Keywords:
- Cancer
- Pain
- Patient in a oncology unit who has to undergo a painful or invasive procedure
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