Do steroids speed recovery after drainage of a quinsy: a randomised, placebo-controlled trial
| ISRCTN | ISRCTN69944535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69944535 |
| Secondary identifying numbers | 07855752109 |
- Submission date
- 23/07/2008
- Registration date
- 27/08/2008
- Last edited
- 28/11/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Patrick Spielmann
Scientific
Scientific
Department of Otolaryngology
Raigmore Hospital
Old Perth Road
Inverness
IV2 3BG
United Kingdom
| Phone | +44 (0)1463 704000 |
|---|---|
| patrickspielmann@nhs.net |
Study information
| Study design | Double-blind, randomised, placebo-controlled, single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Single dose dexamethasone following aspiration of a peri-tonsillar abscess: a randomised, placebo-controlled trial |
| Study objectives | Peri-tonsillar abscess is a common cause for emergency admission to an "Ear, Nose and Throat" (ENT) ward. In Raigmore there are 2-3 admissions per week with a quinsy. The standard management is needle aspiration under local anaesthetic, commonly performed in the ward treatment room. The patient would normally be admitted to the ward for intravenous antibiotics and fluid until they were able to resume a satisfactory oral intake. The length of admission depends very much on the speed of recovery and resumption of normal oral intake; this can vary from 6 hours - 48 hours. Null hypothesis: There is no difference in the rate of recovery between patients given dexamethasone and those given saline after aspiration of a peri-tonsillar abscess. |
| Ethics approval(s) | To be submitted to the Highland Research Ethics Committee as of 23/07/2008 |
| Health condition(s) or problem(s) studied | Peri-tonsillar abscess (quinsy) |
| Intervention | Antibiotics (intravenous [IV]) + dexamethasone 8 mg (single dose) vs antibiotics (IV) + placebo Standard antibiotics treatment would be benzyl-penicillin 1.2 g four times per day (qds) or clarithromycin 500 mg three times per day (tds) if allergic to penicillin. Please note that this trial was stopped in February 2011 due to problems with recruitment and funding. |
| Intervention type | Other |
| Primary outcome measure | 1. Time to resumption of oral intake of fluids and solids 2. Time to resolution of fever 3. Time to resolution of pain |
| Secondary outcome measures | Improvement in inter-incisor distance (i.e. mouth opening as surrogate marker for improvement), measured every 4 hours. |
| Overall study start date | 01/10/2008 |
| Completion date | 01/10/2009 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 |
| Key inclusion criteria | 1. Patient with pus aspirated from peri-tonsillar abscess 2. Both males and females, age over 16 3. Minimum body weight of 40 kg |
| Key exclusion criteria | 1. Children less than 16 may not be able to consent themselves to the study so will not be included 2. A body weight of less than 40 kg means the proposed dose of 8 mg dexamethasone is too high 3. Pregnancy 4. Inability to consent 5. Current symptomatic peptic ulcer |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Otolaryngology
Inverness
IV2 3BG
United Kingdom
IV2 3BG
United Kingdom
Sponsor information
Raigmore Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Patrick Spielmann
Department of Otolaryngology
Old Perth Road
Inverness
IV23BG
Scotland
United Kingdom
"ROR" |
https://ror.org/05apdps44 |
|---|
Funders
Funder type
Research organisation
Grant application has been submitted to the Otolaryngologic Research Society (http://www.ors.uk.net/) (UK). Decision pending as of 23/07/2008.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
