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Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns

NCT00643357 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-01-19

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.

Conditions

  • Burns

Interventions

DRUG

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

gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes

DRUG

50%Oxygen/50% Nitrogen premix

inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

Sponsors & Collaborators

  • Air Liquide Santé International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643357 on ClinicalTrials.gov