A single centre double blind randomised controlled trial investigating the use of dexamethasone in the treatment of acute tonsillitis. - The use of dexamethasone in the treatment of acute tonsillitis.

Phase 1

• Conditions: Acute bacterial tonsillitis

• Registration Number: EUCTR2009-014827-21-GB
• Lead Sponsor: Derby Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 164

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified