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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002101-23-GB
Enrollment
90
Registered
2006-02-06
Start date
2006-02-28
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal deformity requiring corrective surgery i.e Rhinoplasty

Interventions

Trade Name: Dexamethasone Sodium Phosphate Injection 10mg/2ml Pharmaceutical Form: INN or Proposed INN: Dexamethasone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conce

Sponsors

North West London Hospitals NHS Trust, R&D Office
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

MeasureTime frame
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).—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026