Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr H Khalil

ORCID ID

Contact details

ENT Department
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 0117 9505050
research@southmead.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234120874

Study information

Scientific title

Peri-operative antibiotics in tonsillectomy patients

Acronym

Study hypothesis

Does the peri-operative administration of antibiotics improve pain control in adults undergoing tonsillectomy?

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pain

Intervention

Double blind randomised placebo controlled trial.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Visual analogue scale for pain at 24 h, 1 week, 2 weeks
2. Analgesia requirements at end of 2 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2004

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients listed for tonsillectomy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

186

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2004

Recruitment end date

01/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ENT Department
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North Bristol NHS Trust (UK)

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

01/03/2016: No publications found, verifying study status with principal investigator.