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Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS

NCT04189107 · Copenhagen University Hospital, Rigshospitalet · Updated 16 March 2023

What is being tested
Dexamethasone; Placebo
For
Analgesia; Surgery; Cancer of Head and Neck; Oropharyngeal Cancer; Carcinoma of Unknown Primary; Pain, Postoperative; Postoperative Pain
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years and older. About 18 people. The full rules are on the registry page.
Where
Denmark
When
Starts or started 18 Aug 2020, ends 9 Nov 2022. Registered 6 Dec 2019.
Results
None posted yet.

In the researchers' words

This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies. 1. Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period. 2. A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization 3. An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.
ClinicalTrials.gov, NCT04189107

Sites

  • Department of Otorhinolaryngology, Head and Neck Surgery & AudiologyCopenhagen, Denmark