Dysplasia of the hip MedDRA version: 20.0 Level: LLT Classification code 10063175 Term: Hip dysplasia System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Dexavital
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexametason
CAS Number: 312-93-6
Other descriptive name: DEXAMETHASONE PHOSPHATE
Concentration unit: mg/ml millig
Sponsors
Viktoria Lindberg-Larsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing periacetabular osteotomy due to symptomatic hip dysplasia (CE12months amenorrhoea. **Safe contraceptives accepted: intrauterine device or hormone contraceptives. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Patients who cannot speak or understand Danish 2. Allergy or contraindications to trial medication 3. Spinal anaesthesia 4. Second intervention carried out simultaneously (e.g. femur osteotomy) 5. Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted) 6. Drug, medical abuse or weekly alcohol consumption beyond =7 (female) and =14 (men) units, respectively. 7. Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants) 8. Diabetes diagnosed prior to inclusion 9. Immune suppression therapy (e.g. systemic glucocorticoids) 10. Kidney impairment (eGFR < 50ml/min) or liver disease (=Child Pugh B)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of intravenous dexamethasone relative to placebo on cumulated postoperative morphine consumption from baseline to 48 hours in hip dysplasia patients undergoing PAO.;Secondary Objective: To compare the effect of repeated doses of intravenous dexamethasone relative to a single dose on cumulated postoperative morphine consumption from baseline to 48 hours in hip dysplasia patients undergoing periacetabulary osteotomy (PAO). Furthermore, to evaluate postoperative nausea and vomiting and development in inflammatory markers from baseline to 48 hours postoperative. And, to determine if dexamethasone is superior to placebo for: -Perception of pain intensity postoperatively and need for supplemental analgesics -Prevalence and degree of postoperative nausea and vomiting, including antiemetic consumption -Patient-reported outcome measures (PROMs) -Perception of sleep quality -Mobilization postoperatively -Prevalence and degree of serious adverse events (SAE), e.g. complicating wound infection, which need antibiotic treatment or revision surgery. ;Primary end point(s): Cumulated postoperative morphine consumption in milligrams (mg) after 48hours. ;Timepoint(s) of evaluation of this end point: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A Postoperative pain intensity after 48 hrs. Evaluated at (i) rest and (ii) under the timed-up-and-go (TUG) procedure. Pain intensity is assessed using the visual analogue scale (VAS). B Cumulated consumption of opioids from 48hrs post operation to POD14. C Postoperative nausea, 4 point scale after 48hrs. D Cumulated antiemetic consumption in mg and drug will be assessed after 48hrs. E TUG test after 48hrs. F Number of patients with one or more serious adverse events (SAE) G Inflammatory markers;Timepoint(s) of evaluation of this end point: A 48 hours B day 14 after day of surgery C 48 hours D 48 hours E 48 hours F 8 weeks G 48 hours | — |
Countries
Denmark
Contacts
Public ContactViktoria Lindberg-Larsen
Dept. of anaesthesiology and intensive medicine, Odense University Hospital
Outcome results
None listed