High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase

• Status: Completed
• Trial end date: 2019-08-20
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery.

The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• planned unilateral periacetabular osteotomy

• informed signed consent

Exclusion Criteria:

• Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)

• ongoing (<30 days) use of immunosuppressive therapy

• insulin dependent diabetes

• pregnancy/breastfeeding

• allergies toward study medication, or medication in the standard treatment

• surgery cannot be performed