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Nebulized Fentanyl in Healthy Volunteers

ConditionsAnalgesiaEmergencies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-68
SponsorUniversity Hospital, Rouen

About this trial

Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years and < 68 years

BMI between 19 and 29 kg/m²

Affiliation to a social security scheme

Adult who has read and understood the information letter and signed the consent form

Disqualifiers

Weight < 50 kg

Taking long-term painkillers or narcotics

Sharp pain

Stable chronic pain (>3 months, with or without long-term treatment)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fentanyl - Inhalation by facial nebulization

    Drug

    3 administrations based on a weight-dependent threshold (40 µg per administration for a weight \< 70kg and 50 µg per administration for a weight ≥ 70kg).

  • Fentanyl - Nebulisation

    Drug

    3 administrations based on a weight-dependent threshold (20 µg/administration and for a weight \< 70kg and 30 µg/administration for a weight ≥ 70kg). The dose of each bolus will be distributed at equivalent volume in both nasal pits

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Facial NebulizationExperimental treatment 1 intervention
Group B: IntranasalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement of [F] bioavailability via facial nebulization and intranasal inhalation.

Bioavailability \[F\] will be expressed as percent mean +/- standard deviation for each group.

Time frame
6 hours

Secondary outcomes

1

Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation.

Maximum decrease in PUAL will be expressed as percent of baseline value +/- standard deviation for each group.

Time frame
6 hours
2

Measurement of the difference between observed and predicted PUAL values by a PK/PD model.

The difference between observed and predicted values will be expressed as RMSE in percent.

Time frame
6 hours
3

Time required to achieve >30% decrease in PUAL compared to baseline.

Time required for \>30% decrease in PUAL will be expressed in minutes +/- standard deviation for each group.

Time frame
6 hours
4

To assess respiratory tolerance

Using the respiratory rate and pulse oxygen saturation for respiratory tolerance

Time frame
8 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov
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