FENTA: Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT02298582

Collaborator

(none)

Enrollment

Location

Arm

39.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Due to Certain Specified Procedures	Drug: intranasal fentanyl	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.

Actual Study Start Date :

Dec 8, 2014

Actual Primary Completion Date :

Oct 24, 2017

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal fentanyl	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

Arm

Intervention/Treatment

Experimental: Intranasal fentanyl

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

Outcome Measures

Primary Outcome Measures

Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects. [5 days after the last intake of fentanyl.]
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.

Secondary Outcome Measures

Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain. [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).]
VAS will be evaluated during each session at t0, t0+15min, t0+30min, and 1hour after the session (on average at 2 hours)
Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale. [At the end of session of care or rehabilitation (on average at 1 hour).]
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.
Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale [1 hour after the last intake of fentanyl]
Nurse or physiotherapist evaluation satisfaction regarding the convenience of the use of pecfent® and its contribution towards care using a verbal descriptor scale
Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale [At the end of Session of care or rehabilitation (on average at 1 hour).]
Patient evaluation at the end of sessions: - Patient satisfaction regarding the course of the session with a VDS

Eligibility Criteria

Criteria

Ages Eligible for Study:

76 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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