Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms

  • Pain Due to Certain Specified Procedures

NCT number NCT02298582
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Completed
Phase Phase 2/Phase 3
Start date December 8, 2014
Completion date April 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02283463 - Novel Cervical Retraction Device N/A
Recruiting NCT04859049 - Single Injection Infromedial Peribulbar Injection in Lacrimal Duct N/A
Terminated NCT02151136 - Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work? Phase 4
Terminated NCT01438008 - Pilot Study of Sucrose to Reduce Pain in Sick Babies Phase 4
Withdrawn NCT01325090 - Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy Phase 3
Completed NCT02616419 - External Cold and Vibration Stimulation (Buzzy®) for Procedural Pain Management in Children Undergoing Needle-Related Procedures N/A
Completed NCT04987866 - Vibration Anesthesia for Propofol- Rocuronium Injection Pain N/A
Completed NCT02437929 - Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment N/A
Completed NCT02771600 - Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients N/A
Completed NCT03859804 - Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy N/A