ISRCTN ISRCTN52345875
DOI https://doi.org/10.1186/ISRCTN52345875
Protocol serial number N0234120874
Sponsor Department of Health (UK)
Funder North Bristol NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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 H Khalil
Scientific

ENT Department
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Phone +44 0117 9505050
Email research@southmead.swest.nhs.uk

Study information

Primary study designInterventional
Study designRandomised placebo controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific titlePeri-operative antibiotics in tonsillectomy patients
Study objectivesDoes the peri-operative administration of antibiotics improve pain control in adults undergoing tonsillectomy?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPain
InterventionDouble blind randomised placebo controlled trial.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration186
Key inclusion criteriaAdult patients listed for tonsillectomy.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/03/2004
Date of final enrolment01/03/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

ENT Department
Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

16/05/2018: No publications found, verifying study status with principal investigator.
01/03/2016: No publications found, verifying study status with principal investigator.