Study of the Efficacy and Safety of Kalinox® 170 Bar for... | NCT00643357

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

NCT00643357

Sponsor

Air Liquide Santé International

Status

Withdrawn

Last Update Posted

Jan 19, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Burns

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patient recruited due to current guidelines for the pain related to burn

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.

Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.

Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.

The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.

The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)	Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)
B	Placebo Comparator	50%Oxygen/50% Nitrogen premix	Drug: 50%Oxygen/50% Nitrogen premix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)	Drug	gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The intensity of the pain was assessed using the "Faces Pain Scale Revised"		Faces Pain Scale Revised

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
- potentially mildly to moderately painful
- lasting for at least 15 minutes and for less than 30 minutes
- eligible to receive short-term prophylactic analgesic treatment
- for whom the consent form has been signed (parent and child)

Exclusion criteria:

Child treated under general anaesthesia
Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
Child suffering from moderate to severe pain when beginning the care procedure (FPSr > 4)
Exclusion criteria linked to the product

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided