Status:
COMPLETED
Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Pain Due to Certain Specified Procedures
Eligibility:
All Genders
76+ years
Phase:
PHASE2
PHASE3
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 ...
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 session...
Eligibility Criteria
Inclusion
- Hospitalized geriatric patient requiring care or rehabilitation
- Patient with pain during treatment or mobilization. (VAS ≥ 4)
- Written Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02298582
Start Date
December 8 2014
End Date
April 1 2018
Last Update
May 8 2018
Active Locations (1)
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1
University hospital of Grenoble
Grenoble, Isere, France, 38043