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

Burns Clinical Trial

— Burns  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00643357
• Other study ID #: 2006-002698-38
• Status: Withdrawn
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: January 18, 2012
• Start date: March 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2012
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)
gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
• 50%Oxygen/50% Nitrogen premix
inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of the pain was assessed using the "Faces Pain Scale Revised"		Faces Pain Scale Revised	No