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pain relief management by kalinox 170 bar for short-time painful procedure in paediatric patients "alivio del dolor con kalinox 170 bar en pacientes pediatricos sometidos a procedimientos dolorosos de corta duracion" - pain relief management in paediatric patients

pain relief management by kalinox 170 bar for short-time painful procedure in paediatric patients "alivio del dolor con kalinox 170 bar en pacientes pediatricos sometidos a procedimientos dolorosos de corta duracion" - pain relief management in paediatric patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001284-33-ES
Enrollment
150
Registered
2006-05-25
Start date
2006-06-08
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

None listed

Interventions

Trade Name: kalinox 170 bar Product Name: nitrous oxide /oxygen gas mixture Product Code: 3 Pharmaceutical Form: Inhalation gas INN or Proposed INN: nitrous oxide/oxygen gas mixture Concentration type

Sponsors

air liquide sante international
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - paediatrics patients, aged 1 to 18 years- Able to use a Revised FACES Pain Scale (patient > 6 years) -Able to be applied a Spanish Observational Pain Scale “LLANTO SCALE” (patient =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient having already been included in this protocol - Significant impairment in general condition (WHO > 3) - Patient unable to rate pain on Revised FACES Pain Scale (patient > 6 years) - Patient unable to be applied LLANTO SCALE (patient < 6 years) - Confusion- Product-related non-inclusion criteria

Design outcomes

Primary

MeasureTime frame
Main Objective: To show efficacy of KALINOX® 170 bar to reduce pain felt by paediatric patients during various painful procedures ;Secondary Objective: - Evaluation of the feasibility of using KALINOX® 170 bar during various painful procedures - Evaluation of product safety ;Primary end point(s): - Auto-evaluation of pain relief experienced by the patient during invasive procedures (Revised FACES Pain Scale) - Patient behaviour changes in LLANTO SCALE evaluated by the nursing team—

Countries

Spain

Outcome results

None listed

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