NCT00643357: Burns

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

Withdrawn Phase 3 Last updated 18 January 2012

What this trial tests

Phase 3 trial testing 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) in Burns. Withdrawn.

Timeline

1 March 2008

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Air Liquide Santé International
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 March 2008
Primary completion	1 January 2009
Estimated completion	1 January 2009

Drugs / interventions tested

• 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) — full drug profile →
• 50%Oxygen/50% Nitrogen premix

Conditions studied

• Burns — all drugs for Burns →

Sponsor

Air Liquide Santé International — full company profile →

Who can join

Adults 4 to 15, any sex, with Burns. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The intensity of the pain was assessed using the "Faces Pain Scale Revised"
  Time frame: Faces Pain Scale Revised

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.