A Phase 2/3 interventional study of intranasal fentanyl in Pain Due to Certain Specified Procedures, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 76 Years and older. Per ClinicalTrials.gov, last updated 2018-05-08.
Sponsored by University Hospital, Grenoble · Phase 2/3, Interventional, and Treatment
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,
237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 58 is below the median of 83 across 223 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: intranasal fentanyl
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
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.
Time frame: 5 days after the last intake of fentanyl.
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)
Time frame: 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).
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.
Time frame: 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
Time frame: 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
Time frame: At the end of Session of care or rehabilitation (on average at 1 hour).
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble