E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with trauma, musculoskeletal, stomach or back pain on numeric rating scale at least value 4 |
Potilaat, joilla on trauma-, selkä-, vatsa- tai tuki- ja liikuntaelinkipua numeerisella arviointiasteikolla mitattuna vähintään arvon 4 verran. |
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E.1.1.1 | Medical condition in easily understood language |
Subjects are people who call and ambulance and have stomach, limb or back pain or pain caused by accidents |
Tutkittavat ovat potilaita, jotka ovat soittaneet ambulanssin ja heillä on vatsa-, raaja-, tai selkäkipua, tai heillä on onnettomuudesta johtuvaa kipua |
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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 |
Objective is to gather information about how intranasal fentanyl works as pre-hospital analgesic. Main point is in efficacy, safety and reliability of the drug. |
Tavoite on saada tietoa intranasaalisen fentanyylin toimivuudesta ensihoidon kipulääkkeenä. Pääpaino on lääkkeen teholla, turvallisuudella ja luotettavuudella |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject is over 18 years old, have trauma, muscoskeletal, stomach or back pain on numeric rating scale at least value 4 |
Tutkittava on yli 18-vuotias, jolla on trauma-, selkä-, vatsa- tai tuki- ja liikuntaelinkipua numeerisella arviointiasteikolla mitattuna vähintään arvon 4 verran. |
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E.4 | Principal exclusion criteria |
Nasal bleeding, nasal or head trauma, respiratory rate less than 10, systolic blood pressure less than 100, state of conciousness on GCS less than 15, known allergy or hypersensitivity to fentanyl, obstructive pulmonary disease. No patients in vunerable groups. |
Nenäverenvuoto, nenän tai pään alueen vamma, hengitystaajuus alle 10, systolinen verenpaine alle 100, tajunnantaso GCS:lla alle 15, allergia tai yliherkkyys fentanyylille, ahtauttava keuhkosairaus. Tutkittavia ei oteta eritysryhmistä. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is reduction of pain intensity score on visual analog scale |
Ensisijainen päätemuuttuja on kivun voimakkuuden lasku potilaalla visual analog scale -asteikon mukaan |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints are: Before medication, 2 minutes after medication, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes Study might be stopped before some timepoints are reached due to the transport of patient into hospital |
Aikapisteet ovat: Ennen lääkitystä, 2 minuuttia lääkityksen jälkeen, 5 minuuttia, 10 minuuttia, 15 minuuttia, 20 minuuttia, 30 minuuttia Tutkimus voidaan lopettaa ennen kuin kaikki aikapisteet saavutetaan, koska potilas luovutetaan jatkohoitoon joka tapauksessa |
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E.5.2 | Secondary end point(s) |
Secondary end points are paramedics evaluation of pain reduction, blood pressure, respiratory rate, state of conciousness and other possibly appeared adverse effects |
Toissijaiset aikapisteet ovat hoitajan arvio tehosta, verenpaine, hengitystaajuus, tajunnantaso sekä muut mahdollisesti ilmenneet haittavaikutukset |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints are: Before medication, 2 minutes after medication, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes Study might be stopped before some timepoints are reached due to the transport of patient into hospital |
Aikapisteet ovat: Ennen lääkitystä, 2 minuuttia lääkityksen jälkeen, 5 minuuttia, 10 minuuttia, 15 minuuttia, 20 minuuttia, 30 minuuttia Tutkimus voidaan lopettaa ennen kuin kaikki aikapisteet saavutetaan, koska potilas luovutetaan jatkohoitoon joka tapauksessa |
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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 | 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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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 | |