Phase 4 N=64 Randomized Quadruple-blind Treatment

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

Hip Dysplasia · Postoperative Complications

Bottom Line

View on ClinicalTrials.gov: NCT03161938 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Apr 2020

Primary outcome: Primary: Number of Participants With Moderate to Severe Postoperative Pain — 26; 22 Participants — p=0.248

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rigshospitalet, Denmark
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Moderate to Severe Postoperative Pain	26; 22	0.248
SECONDARY Lenght of Stay, PACU	2; 3	0.519
SECONDARY Lenght of Stay, Hospital	78; 77	0.468
SECONDARY Pain Scores, PACU	5; 5; 2; 2	0.913
SECONDARY Complications	24; 25	0.768
SECONDARY Self Reported Postoperative Pain	3; 4; 4; 4; 3; 4	0.133
SECONDARY Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4	7; 8; 6; 9; 9; 11	0.768
SECONDARY Number of Patients With Sleep Problems	13; 12; 9; 13; 8; 9	>0.999
SECONDARY Number of Patients With Feelings of Anxiety, Unrest and/or Sadness	8; 2; 11; 8; 23; 21	0.075
SECONDARY Number of Patients Readmitted to Hospital Within 30 Days	1; 3	0.613
SECONDARY Number of Patients With Wound Infections Within 30 Days	0; 0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03161938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.