Study where a pain medicine (fentanyl) is administered through nostrils and into nasal cavity by paramedics in an out-of-hospital situations. The efficacy and safety of the medicine is assessed in those situations.
- Conditions
- Patients with trauma, musculoskeletal, stomach or back pain on numeric rating scale at least value 4Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-005286-69-FI
- Lead Sponsor
- Kuopion yliopistollinen sairaala/Ensihoitokeskus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Subject is over 18 years old, have trauma, muscoskeletal, stomach or back pain on numeric rating scale at least value 4
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint is reduction of pain intensity score on visual analog scale;Timepoint(s) of evaluation of this end point: Timepoints are:<br>Before medication, 2 minutes after medication, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes<br>Study might be stopped before some timepoints are reached due to the transport of patient into hospital
- Secondary Outcome Measures
Name Time Method 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;Timepoint(s) of evaluation of this end point: Timepoints are:<br>Before medication, 2 minutes after medication, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes<br>Study might be stopped before some timepoints are reached due to the transport of patient into hospital