Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal fentanyl | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal fentanyl | Drug | During the two first sessions of care or rehabilitation, patients do not receive Pecfent® in order to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care. A titration of PecFent will be done at each session |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects. | The nature and frequency of adverse effects will be described. The collection of adverse events will be first, with the collection of spontaneous patient complaints from nurses on the other hand, by systematic screening with the patient. Monitoring of respiratory rate and level of sedation will also be set up. | 5 days after the last intake of fentanyl. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain. | VAS will be evaluated during each session at t0, t0+15min, t0+30min, and 1hour after the session (on average at 2 hours) | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Grenoble | Grenoble | Isere | 38043 | France |
Not provided
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale. | At the end of each session of care or rehabilitation, it will be proposed to the caregiver, a scale measuring its satisfaction regarding the objectives achieved during the session. | At the end of session of care or rehabilitation (on average at 1 hour). |
| Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale | Nurse or physiotherapist evaluation satisfaction regarding the convenience of the use of pecfent® and its contribution towards care using a verbal descriptor scale | 1 hour after the last intake of fentanyl |
| Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale | Patient evaluation at the end of sessions: - Patient satisfaction regarding the course of the session with a VDS | At the end of Session of care or rehabilitation (on average at 1 hour). |