E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
adult patients undergoing negative pressure wound therapy dressing change |
alipaineimulaitteen sidevaihtoon tulevia aikuispotilaita |
|
E.1.1.1 | Medical condition in easily understood language |
adult patients undergoing negative pressure wound therapy dressing change |
alipaineimulaitteen sidevaihtoon tulevia aikuispotilaita |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10074212 |
E.1.2 | Term | Vacuum assisted wound closure |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
to reduce pain and the need of rescue fentanyl during negative pressure wound therapy dressing change associated pain |
haavan alipaineimuliatteen sidevaihtoon liittyvön kivun ja lisäkipulääkityksen tarpeen vähentäminen |
|
E.2.2 | Secondary objectives of the trial |
evaluating haemodynamic changes and possible confusion |
hemodynaamisten muutosten ja mahdollisen sekavuuden esiintymisen arviointi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
adult patients undergoing negative pressure wound therapy dressing change |
haavan alipaineimulaitehoitoon kuuluvaan sidevaihtoon tulevia aikuispostilaita |
|
E.4 | Principal exclusion criteria |
BMI >40, ischemic cardiac disease, increased intracranial pressure, increased intraocular pressure, graviidity, lactation, hypersensitivity or allegy to ketamine, fentanyl or midazolam, severe psychiatric disease, drug addiction, unability to use NRS-pain scale |
BMI >40, iskeeminen sydänsairaus, kohonnut kallon- tai silmänsisäinen paine, raskaus, imetys, yliherkkyys, ketamiinille, fentanyylille tai midatsolaamille, vakava psykiatrinen sairaus, päihderiippuvuus, kyvyttömyys käyttää NRS-kivunmittausmenetelmää |
|
E.5 End points |
E.5.1 | Primary end point(s) |
pain during negative pressure wound therapy dressing change, the need of rescue fentanyl (an opiodi) during the procedure) |
toimenpiteen aikainen kipu, lisäkipulääkkeen (fentanyyli) tarve |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
pain at the beginning of the procedure and at 15 minutes, 30 minutes, 45 minutes and 60 minutes, after 3 months |
kipu ennen toimenpidettä, 15min. , 30 min., 45 min. ja 60 min. kohdalla toimenpiteestä sekä 3 kk kuluttua. |
|
E.5.2 | Secondary end point(s) |
evaluation of hemodynamic changes /heart rate, blood pressure) and oxygen saturation, evaluation of confusion |
hemodynaamisten muuttujien ja happisaturaation sekä sekavuuden esiintymisen arviointi |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
15, 30, 45 and 60 minutes for RR, p, Sp02 15 and 60 minutes for confusion using RASS-scale (Richmond Agitation Sedation scale) |
sykkeen, verenpaineen ja happisaturaation mitatus 15min, 30min, 45min ja 60 min kohdalla Sekavuuden arviointi 15min ja 60 min kohdalla käyttäen RASS-asteikkoa (Rinchmond Agitation Sedation Scale) |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | 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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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
|
3 months after the procedure |
Toimenpiteen jälkeen 3 kk kohdalla kun potilaalle soitetana ja kysytään senhetkisen kivun esiintymisestä toimenpitealueella |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |