E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
children under the age of three that are in possession of a central catheter and under permanent monitoring (healthy, or any condition) |
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E.1.1.1 | Medical condition in easily understood language |
children under the age of three that are in possession of a central catheter (in order to take blood samples) and under permanent medical supervision by a monitor and professionals |
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E.1.1.2 | Therapeutic area | Health Care [N] - Health Care Economics and Organizations [N03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
evaluating the ease of use of applying a S-Caine Patch in children younger than three |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
time (min): 0-15-30-60-120- (later) |
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E.5.2 | Secondary end point(s) |
evaluate the ease of use of the existing S-Caine patch in children younger than three |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
time (min): 0-15-30-60-120- (later) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
each patient is its own control |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |