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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion

NCT00643656

Liver Biopsy

COMPLETED PHASE4

Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain

NCT01356745

Acute Pain

COMPLETED PHASE4

Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.

NCT00219713

Pain

TERMINATED PHASE3

Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial

NCT02243826

Lumbar Puncture

UNKNOWN PHASE4

Intravenous (IV) Lidocaine for Opioid-refractory Pain

NCT00321347

Neoplasms Pain

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

gas flow between 4 to 15 L/min

B

50% oxygen/50% Nitrogen premix

Group Type PLACEBO_COMPARATOR

50% Oxygen/50% Nitrogen premix

Intervention Type DRUG

gas flow between 4 to 15 L/min

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

gas flow between 4 to 15 L/min

Intervention Type DRUG

50% Oxygen/50% Nitrogen premix

gas flow between 4 to 15 L/min

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No