E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paediatric patients scheduled for minor procedures such as intra-articular drug injections, hernia repair, bronchoscopy or magnetic resonance imaging. |
Lapsipotilaat jotka tulevat pieneen yleisanestesiaa vaativaan toimenpiteeseen, kuten intra-artikulaarinen lääkeinjektio, hernioplastia, bronkoskopia tai MRI-kuvaus |
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E.1.1.1 | Medical condition in easily understood language |
Paediatric patients scheduled for minor procedures such as drug injection in to the joints, hernia repair, bronchoscopy or magnetic resonance imaging |
Lapsipotilaat jotka tulevat pieneen yleisanestesiaa vaativaan toimenpiteeseen, kuten nivelen sisäinen lääkkeenanto, tyräkorjaus, keuhkojen tähystys tai magneettikuvaus. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
We aim to characterize the pharmacokinetics of dexmedetomidine after intranasal dosing. |
Deksmedetomidiinin farmakokinetiikan karakterisointi nenään annostellun lääkeannoksen jälkeen. |
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E.2.2 | Secondary objectives of the trial |
We will also monitor the haemodynamic effects, local and systemic safety and local tolerability of intranasally administered dexmedetomidine |
Deksmedetomidiinin verenkiertovaikutukset, paikallinen ja systeeminen turvalliusuus ja paikallinen siedettävyys nenäannostelun jälkeen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The child is scheduled for intra-articular drug injections, hernia repair, bronchoscopy or another similar minor procedure or magnetic resonance imaging requiring sedation or anesthesia 2. Guardians and patients (if relevant) with fluent skills in the Finnish or Swedish language (to understand the given information, to be able to give informed consent and communicate with the study personnel). 3. Age between 1 month and 12 years. 4. Normal developmental status including growth (SD -1.5-1.5) 5. Written informed consent from the guardian and the patient (when relevant). |
1. Potilaalle on ohjelmoitu sedaatiota tai yleisanestesiaa vaativa intra-artikulaarinen lääkeinjektio, hernioplastia, bronkoskopia tai vastaava pieni toimenpide tai magneettikuvaus. |
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E.4 | Principal exclusion criteria |
1 A previous history of intolerance to the study drug or to related compounds and additives 2. Prior drug therapy with dexmedetomidine in the 14 days prior to the study. 3. Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed. 4. Existing or recent significant disease that could influence the study outcome or cause a health hazard for the subject if he/she would participate in the study. 5. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study. 6. Clinically significant abnormal findings in physical examination or laboratory screening [routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)].
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1. Yliherkkyys tutkimuksessa käytettävälle lääkkeelle tai sen apuaineille. 2. Deksmedetomidiinilla toteutettu lääkehoito 14 päivää ennen tutkimusta. 3. Deksmedetomidiinin aineenvaihduntaan vaikuttavan lääkeaineen/-aineiden käyttö tutkimusta edeltävän kuukauden aikana. 4. Aikaisempi lääkeaineiden imeytymiseen, jakautumiseen, aineenvaihduntaan ja/tai eritykseen vaikuttava sairaus 5. Osallistuminen muuhun lääketutkimukseen alle kuukautta edeltävällä ajalla tästä tutkimuksesta. 6. Kliinisesti merkittävät poikkeavuudet lääkärin tutkimuksessa, EKG:ssa tai laboratorioarvoissa |
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E.5 End points |
E.5.1 | Primary end point(s) |
The bioavailability of intranasally given dexmedetomidine in children as characterized against previously available intravenous study data |
Nenään annostellun deksmedetomidiinin hyötyosuus lapsilla, verrattuna aikaisempaan laskimonsisäisesti toteutettuun annosteluun. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 h after administration |
24 tuntia annostelun jälkeen |
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E.5.2 | Secondary end point(s) |
The pharmacokinetics and –dynamics of intranasally given dexmedetomidine in children.
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Nenään annostellun deksmedetomidiinin farmakokinetiikka ja -dynamiikka lapsilla. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 h after administration |
24 tuntia annostelun jälkeen |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
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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LVLS |
Viimeinen tutkimuskäynti suoritettu. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |