Acute bacterial tonsillitis
Conditions
Interventions
Trade Name: Dexamethasone 8.0mg/2ml Injection (Organon Laboratories Ltd)
or
Dexamethasone Sodium Phosphate 8mg/2ml Injection (Hospira)
Product Name: Dex
Sponsors
Derby Hospitals NHS Foundation Trust
Derby Hospitals NHS Foundations Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Patients must be: 1. Over 16 years of age 2. Being admitted to hospital with acute tonsillitis (characterised by: bilateral sore throat with the inability to eat & drink +/- fever & evidence on examination of inflamed and/or exudative tonsils) Exclusion Criteria 1.Patients who have a history of diabetes 2.Patients who are on regular systemic steroids 3.Patients who have used a course of oral/intravenous steroids in the last month 4.Patients who have a history of allergy to dexamethasone or any excipients 5.Patients with peritonsillar abscess on clinical examination 6.Patients with asymmetry of the tonsils on clinical examination 7.Patients with deep neck space infections on clinical examination 8.Patients with a positive urinary pregnancy test 9.Patients with abnormal lymphocytosis on full blood count 10.Patients who do not have the mental capacity to consent 11.Patients who are unable to understand written or verbal information in English 12. Patients admitted to hospital with acute tonsillitis between 8pm and 8am. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of diabetes 2. Patients who are on regular systemic steroids 3. Patients who have used a course of oral/intravenous steroids in the last month 4. Patients who have a history of allergy to dexamethasone or any excipients 5. Patients with peritonsillar abscess on clinical examination 6. Patients with asymmetry of the tonsils on clinical examination 7. Patients with deep neck space infections on clinical examination 8. Patients with a positive urinary pregnancy test 9. Patients with previously or presently abnormal lymphocytosis on full blood count 10. Patients who do not have the mental capacity to consent 11. Patients who are unable to understand written or verbal information in English 12. Patients admitted to hospital with acute tonsillitis between 8pm and 8am 13. Patients with acute tonsillitis and signs of airway compromise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess if the addition of a single dose of dexamethasone, to the treatment of acute tonsillitis with intravenous antibiotics, analgesia and intravenous fluids speeds up the ability to eat and drink.; Secondary Objective: Secondary Study Endpoints 1.The time taken for patients to go from being unable to swallow solids and liquids to being able to swallow solids and liquids with some discomfort. 2.The proportion of patients ‘swallowing with some discomfort’ on admission, 6 hours, 24 hours 36 hours and 48 hours in standard and treatment group. 3.Pain Scores using a visual analogue scale of 0 to 10, documented at the same time as “swallowing” scores 4.The time of discharge in both groups. ; Primary end point(s): The aim of this study is to assess if the addition of a single dose of dexamethasone, to the treatment of acute tonsillitis with intravenous antibiotics, analgesia and intravenous fluids speeds up the ability to eat and drink. | — |
Countries
United Kingdom
Outcome results
None listed