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.

Intranasal fentanyl in pre-hospital analgesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005286-69-FI

Enrollment

100

Registered

2015-02-10

Start date

2015-02-23

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with trauma, musculoskeletal, stomach or back pain on numeric rating scale at least value 4

Interventions

Trade Name: Instanyl Pharmaceutical Form: Nasal spray, solution in single-dose container INN or Proposed INN: Fentanyyli Other descriptive name: FENTANYL Concentration unit: µg microgram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
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: 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	—

Measure

Time frame

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: 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

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Primary

Measure	Time frame
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: 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	—

Measure

Time frame

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: 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

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Countries

Finland

Contacts

Public ContactEnsihoitokeskus

Kuopion yliopistollinen sairaala

+35817174 085

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026