E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pediatric burn patients who need rectal sedation during wound care |
Brännskade barn som behöver rektal sedering under sårvård. |
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E.1.1.1 | Medical condition in easily understood language |
Pediatric burn patients who need rectal sedation during wound care |
Brännskade barn som behöver rektal sedering under sårvård. |
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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 |
The objective of this study is to compare the effects of three different doses of rectally administrated Ketamine in pediatric burn wound care |
Syftet med denna studie är att jämföra effekten hos tre olika doser av rektalt administrerat ketamin vid pediatrisk brännskadevård.
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E.2.2 | Secondary objectives of the trial |
not applicable |
ej tillämpningsbart
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Children aged 0.5-4 years and weighing over 7 kg and below 38 kg.
• Burns requiring sedation at least three occasions after written consent could be obtained.
• Written consent from the child's guardian or legal representative
• Swedish-speaking parents alt. interpreter on site
• Fasting from food at least 6 hours, breast milk 4 hours and clear liquids 2 hours before initiation of sedation |
•Barn i åldern 0,5-4 år och med en kroppsvikt över 7 kg och under 38 kg.
•Brännskador som kräver sedering vid minst tre tillfällen efter att skriftligt samtycke kunnat inhämtas.
•Skriftligt samtycke från barnets vårdnadshavare alternativt legala ställföreträdare
•Svensktalande föräldrar alt. tolk på plats
•Fastande från mat minst 6 timmar, modersmjölk 4 timmar och klar dryck 2 timmar innan påbörjad sedering |
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E.4 | Principal exclusion criteria |
•Rectal / anal pathology
• Children who require intensive care for their burns (continuous sedation and respiratory needs)
• Treatment or illness that according to the investigator may affect the treatment or study results
• Participation in another clinical trial
• Previous participation in this study.
• Known / suspected allergy or contraindication * against any product included in the study |
•Rektala/anala patologiska tillstånd
•Barn som kräver intensivvård för sina brännskador (kontinuerligt sedering- och respiratorbehov)
•Behandling eller sjukdom som enligt prövaren kan påverka behandlingen eller studieresultatet
•Deltagande i annan läkemedelsprövning
•Tidigare deltagande i denna studie.
• Känd/misstänkt allergi eller kontraindikation* mot någon produkt som ingår i studien
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is pain/anxiety
Secondary variables are the presence of side effects, recovery time, acceptance of treatment and sedation level.
Safety variables are saturation, respiratory and heart rate, blood pressure and documentation of AE and SAE reporting. What is considered an AE is defined in the study protocol |
Den primära effektmåttet är smärta/oro
Sekundära effektmått är närvaro av biverkningar, tid för återhämtning, acceptans av behandling och sederingsgrad.
Säkerhetsvariabler är saturation, andnings- och hjärtfrekvens, blodtryck och dokumentering av AE och rapportering av SAE. Vad som anses vara en AE definieras i studieprotokollet under rubrik
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary endpoint; Before, during and after sedation/wound care.
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Primärt effektmått, Före, under och efter sedering / sårvård.
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E.5.2 | Secondary end point(s) |
Secondary endpoints; during and after sedation
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Sekundära effektmått, under och efter sedering
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety variables (vital signs) are evaluted every fifth minute. |
Säkerhet variabler (vitala) kontrolleras var femte minut fram till avslutad sårvård |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Samtliga barn erhåller samtliga tre doser (vid olika tillfällen) i randomiserad ordning |
each child receive all 3 possible doses (at diffrent occasions) in randomized order. |
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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 |
Olika doser av samma läkemedel (4,6 eller 8 mg/kg) |
Diffrent doses of the same drug (4,6 or 8 mg/kg) |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |