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

NCT02298582 | Completed Phase 2

• 1 other identifier: DCIC/13/67
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Due to Certain Specified Procedures

Keywords

safety; procedural pain; intranasal fentanyl; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

• 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).

• Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by 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

  At the end of Session of care or rehabilitation (on average at 1 hour).

Study Arms (1)

Intranasal fentanyl

EXPERIMENTAL

Drug: intranasal fentanyl

Interventions

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

Intranasal fentanyl

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hospitalized geriatric patient requiring care or rehabilitation
• Patient with pain during treatment or mobilization. (VAS ≥ 4)
• Written Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University hospital of Grenoble

Grenoble, Isere, 38043, France

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: November 24, 2014
• Study Start: December 8, 2014
• Primary Completion: October 24, 2017
• Study Completion: April 1, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

FR (1)