Phase 4
Completed N=64
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase
Hip Dysplasia · Postoperative Complications
Source: ClinicalTrials.gov NCT03161938 ↗
Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Moderate to Severe Postoperative Pain — 26; 22 Participants — p=0.248
◆ Published Evidence
Emerging
12citations · ~2 / year
Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone.
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.
Linked Publications
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Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03161938) and the linked publication. 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. Informational only — not medical advice.