Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly (FENTA)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Pain Due to Certain Specified Procedures

Treatments

Drug: intranasal fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT02298582

DCIC/13/67

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.

Full description

This is a safety clinical trial. This trial is monocentric, open label, non-randomized.

Sixty elderly patients will be enrolled in this study, 30 with bedsore cares and 30 with rehabilitation sessions.

Six bedsore cares or rehabilitation sessions will be assessed for each subject. For each session, patient pain will be evaluated using a visual analogic scale VAS at different times, before session, 5 minutes then 20 minutes after the beginning of the session, and a last VAS 1 hour after the end of the session. During the two first sessions, patients do not receive Pecfent® to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care.

An evaluation of respiratory rate and of the level of sedation will occur at different time : after 5 minutes then 20 minutes of care, at the end of the care session,at half an hour then one hour after the care session.

At the end of sessions,

The nurse or physiotherapist will assess their satisfaction regarding the objectives achieved during the session with a four points verbal descriptor scale (very satisfied, satisfied, not much satisfied, not satisfied). They will also evaluate at the end of the four last session their satisfaction regarding the convenience of the use of pecfent® and its contribution towards care.
Patients will assess their satisfaction regarding the course of the session with a verbal descriptor scale (VDS) and their level of anxiety felt during the session with a VAS.

Enrollment

58 patients

Sex

All

Ages

76+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hospitalized geriatric patient requiring care or rehabilitation
Patient with pain during treatment or mobilization. (VAS ≥ 4)
Written Informed consent

Exclusion criteria

All unstable fractures
Confusion: unable to assess their level of pain using a VAS.
Contraindications to PecFent ® (. Hypersensitivity to the active substance or to any of the excipients listed in section Composition Use in patients who had never received treatment for opioid severe respiratory depression or severe obstructive pulmonary disease.)
Person under legal protection