Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)

PHASE3CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

June 30, 2019

Primary Completion Date

March 6, 2020

Study Completion Date

March 6, 2020

Conditions
Hip Fractures (ICD-10 72.01-72.2)
Interventions
DRUG

Fentanyl Transdermal System

Patients will be treated perioperatively with a new pain management, that has been modified to integrate the 2017 ESA guidelines on prevention/treatment of postoperative delirium. Moreover patients will be administered a 12µg/h Fentanyl TTS in the ER or PACU. The ER TTS will only be administered if the patients still has mild to intense pain after initial intravenous (i.v.) treatment as well as reposition of the fractured hip. Further aspects of the modified management are: avoiding benzodiazepines, allowing oral fluids up to 2 hours before surgery, intraoperative monitoring of anaesthesia depth and at least 1,8 ltr crystalloid infusion per day.

DRUG

Placebo

Placebo plaster in the ER or PACU

Trial Locations (1)

8036

Medical University Hospital LKH Graz, Graz

All Listed Sponsors
lead

Medical University of Graz

OTHER

NCT04026022 - Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS) | Biotech Hunter | Biotech Hunter