Condition category
Infections and Infestations
Date applied
23/07/2008
Date assigned
27/08/2008
Last edited
28/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Patrick Spielmann

ORCID ID

Contact details

Department of Otolaryngology
Raigmore Hospital
Old Perth Road
Inverness
IV2 3BG
United Kingdom
+44 (0)1463 704000
patrickspielmann@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07855752109

Study information

Scientific title

Single dose dexamethasone following aspiration of a peri-tonsillar abscess: a randomised, placebo-controlled trial

Acronym

Study hypothesis

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

To be submitted to the Highland Research Ethics Committee as of 23/07/2008

Study design

Double-blind, randomised, placebo-controlled, single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

01/10/2009

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102

Participant 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

Recruitment start date

01/10/2008

Recruitment end date

01/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Otolaryngology
Inverness
IV2 3BG
United Kingdom

Sponsor information

Organisation

Raigmore Hospital (UK)

Sponsor details

c/o Mr Patrick Spielmann
Department of Otolaryngology
Old Perth Road
Inverness
IV23BG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Grant application has been submitted to the Otolaryngologic Research Society (http://www.ors.uk.net/) (UK). Decision pending as of 23/07/2008.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes