children under the age of three that are in possession of a central catheter and under permanent monitoring (healthy, or any condition)
Conditions
Interventions
Trade Name: Rapydan patch (medicated plaster)
Product Name: Rapydan
Product Code: SE/H/0762/001
Pharmaceutical Form: Medicated plaster
Pharmaceutical form of the placebo: Transdermal patch
Route of ad
Sponsors
Universitair Ziekenhuis Brussel, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting the following criteria were eligible for inclusion in the study: all patients who were - children up to the age of three - admitted to the hospital and monitored - judged by a physician to have stable vital signs - in possession of a peripheral or central venous or arterial catheter allowing blood sampling - granting written informed consent, signed and dated by a legal guardian of the subject Are the trial subjects under 18? yes Number of subjects for this age range: 100 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: Subjects were to be excluded from study participation based on any of the following criteria: patients who: - were older than three - were not admitted - were in absence of a catheter allowing unrestricted blood sampling - showed life threatening pathology (respiratory, circulatory or neurological impairment or instability) or needed a warming blanket in the 24 hours prior to inclusion - had metabolic, liver or kidney diseases, were prematurely born (gestational age < 37 weeks), or suffered from bronchopulmonary dysplasia - suffered from methaemoglobinaemia - suffered from anaemia defined as either plasma haemoglobin levels < 11g/dL and/or haematocrit levels of below 30%. - suffered from skin diseases preventing the use of patches (hypersensitive skin, atopic dermatitis, damaged, denuded or broken skin at the designated patch site,…) - suffered from known allergy or sensitivity to lidocaine and/or tetracaine or other local anaesthetics of the amide or ester type - suffered from known sensitivity to one of the components of the S-Caine Patch (e.g. sulphites, adhesives, …) - received products containing lidocaine, and/or tetracaine within 24 hours before inclusion - patients with history of the use of cocaine, or other drugs that might cause an additive pharmacological affect with either lidocaine and/or tetracaine. Subjects younger than 2 years old or still receiving breast feeding would be excluded if the mother had a history of cocaine use. - did not have parents sign informed consent - were withdrawn by their parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to evaluate safety and feasibility of the use of S-Caine Patch in children younger than three years old, by (1) determining plasma levels of lidocaine following skin application of one S-Caine Patch; (2) monitoring local and systemic possible adverse events after application of one S-Caine Patch;Secondary Objective: evaluating the ease of use of applying a S-Caine Patch in children younger than three;Primary end point(s): Analyse plasma lidocaine levels in order to determine if they stay within safe limits for children under the age of three; monitor possible (new) adverse effects (local and systemic) of the use of the S-Caine patch in children younger than three;Timepoint(s) of evaluation of this end point: time (min): 0-15-30-60-120- (later) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): evaluate the ease of use of the existing S-Caine patch in children younger than three;Timepoint(s) of evaluation of this end point: time (min): 0-15-30-60-120- (later) | — |
Countries
Belgium
Contacts
Public ContactCentraal Studieloket Clinical Trial
Universitair Ziekenhuis Brussel, Belgium
Outcome results
None listed