Pain Due to Certain Specified Procedures Clinical Trial
— FENTAOfficial title:
Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.
Verified date | May 2018 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2018 |
Est. primary completion date | October 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 76 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital of Grenoble | Grenoble | Isere |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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 | |
Secondary | 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). |
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