Do Steroids Provide Additional Benefit Over Pressure Alone In Reducing Oedema And Ecchymosis Following Rhinoplasty? A Randomised, Prospective, Double Blind, Placebo Controlled Clinical Trial - Steroids & Rhinoplasty RCT
- Conditions
- asal deformity requiring corrective surgery i.e Rhinoplasty
- Registration Number
- EUCTR2005-002101-23-GB
- Lead Sponsor
- orth West London Hospitals NHS Trust, R&D Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
All adult patients requiring standard rhinoplasty involving osteotomies.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(1) Allergy to steroids,
(2) A history of peptic ulcer disease,
(3) Non Steroidal Anti Inflammatory Drug Intolerance, e.g. Asthma
(4) Revision rhinoplasty
(5) A history of psychiatric illness
(6) Diabetes Mellitus
(7) Osteoporosis
(8) Hypertension
(9) Congestive Heart Failure
(10) Glaucoma
(11) Epilepsy
(12) Liver failure
(13) History of Tuberculosis
(14) Migraine
(15) Renal insufficiency
(16) Certain parasitic infections e.g. amoebiasis
(17) Cushing’s Syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether steroids provide additional benefit over digital pressure alone in reducing post-operative periorbital oedema (swelling) and ecchymosis (bruising) following rhinoplasty.;Secondary Objective: ;Primary end point(s): Patients will be assessed for any reduction in post-operative eyelid oedema and ecchymosis using a validated scoring system (see Fig 1 and 2 of trial protocol).
- Secondary Outcome Measures
Name Time Method