Clinical trial NCT02298582: Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly
Official title: Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain Due to Certain Specified Procedures
Keywords: safety
procedural pain
intranasal fentanyl
elderly
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 58
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects.
timeFrame: 5 days after the last intake of fentanyl.
Secondary outcomes:
measure: Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain.
timeFrame: Evolution of the level of pain (VAS) since the beginning of care until one hour after the end of session (on average at 2 hours).
measure: Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale.
timeFrame: At the end of session of care or rehabilitation (on average at 1 hour).
measure: Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale
timeFrame: 1 hour after the last intake of fentanyl
measure: Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale
timeFrame: At the end of Session of care or rehabilitation (on average at 1 hour).
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University hospital of Grenoble
state: Isere
Study officials:
References: