STUDY OF THE EFFICACY AND SAFETY OF KALINOX® 170 BAR FOR THE PERFORMANCE OF CARE PROCEDURES IN CHILDREN WITH BURNS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002698-38-BE

Enrollment

180

Registered

2006-11-23

Start date

2006-11-24

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study of the efficacy and tolerance of Kalinox 170 bar for the performance of care procedures in children with burn.

Interventions

Trade Name: Kalinox 170 bar Product Name: kalinox 170 bar Product Code: 03 Pharmaceutical Form: Inhalation gas Pharmaceutical form of the placebo: Inhalation gas Route of administration of the placebo

Eligibility

Inclusion criteria

Inclusion criteria: Child between 5 and 15 years of age burned since few days and who has to undergo at least three burn-care procedures per day. ·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) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 - Exclusion criteria linked to the product

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of Kalinox® 170 bar, over a period of three care procedures in children with burns in the epidermization phase which can be dressed without general anaesthesia.;Secondary Objective: To assess the safety of Kalinox® 170 bar.;Primary end point(s): Relative efficacy score: mean of the differences between the 9 scores for each care procedure (3 painful episodes/dressing: assessment of the intensity of the pain Before, During and After the episode), and the baseline for the care procedure.The intensity of the pain was assessed using the «Faces Pain Scale Revised»	—

Measure

Time frame

Main Objective: To assess the efficacy of Kalinox® 170 bar, over a period of three care procedures in children with burns in the epidermization phase which can be dressed without general anaesthesia.;Secondary Objective: To assess the safety of Kalinox® 170 bar.;Primary end point(s): Relative efficacy score: mean of the differences between the 9 scores for each care procedure (3 painful episodes/dressing: assessment of the intensity of the pain Before, During and After the episode), and the baseline for the care procedure.The intensity of the pain was assessed using the «Faces Pain Scale Revised»

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Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026