Trials Sponsors Conditions Drugs Pricing

Conditions

Pain Due to Certain Specified Procedures

Keywords

safetyprocedural painintranasal fentanylelderly

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 fentanylDrug

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

Age76 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

University Hospital, Grenoble
Otherlead

Study Sites (1)

University hospital of Grenoble

Grenoble, Isere, 38043, France

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

58 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Intranasal fentanyl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Intranasal fentanyl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations