Condition category
Ear, Nose and Throat
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/10/2009
Prospective/Retrospective
Retrospectively 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 A E Camilleri

ORCID ID

Contact details

Clinical Director and Consultant ENT surgeon
University Hospital of South Manchester Foundation Trust
Alexandra BMI Hospital
University of Manchester
Manchester
M23 9LT
United Kingdom
+44 (0)161 217 3734
andrew.camilleri@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226132778

Study information

Scientific title

Acronym

Study hypothesis

To determine which of the two local anaesthetic agents i.e. EMLA (Eutectic mixture of local anaesthetics) or Ametop (topical amethocaine) provides better local anaesthetic effect during grommet insertions

Ethics approval

Provided by South Manchester Research Ethics Committee

Study design

Double blind randomised controlled 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

Ear, Nose and Throat: Grommet insertions

Intervention

EMLA (Eutectic mixture of local anaesthetics) or Ametop (topical amethocaine) for grommet insertion

Intervention type

Drug

Phase

Not Applicable

Drug names

mixture of local anaesthetics or topical amethocaine

Primary outcome measures

Measuring pain on visual analogue score

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/11/2003

Overall trial end date

15/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

40 patients over 18 years of age requiring grommet insertion under local anaesthetic

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Added 19/10/09: children and adult patients not willing to sign consent form.

Recruitment start date

15/11/2003

Recruitment end date

15/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Director and Consultant ENT surgeon
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Manchester University Hospitals 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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18665031

Publication citations

  1. Results

    Nichani J, Camilleri AE, Broomfield S, Saeed S, Optimizing local anesthesia for grommet insertion: eutectic mixture of local anaesthetics versus Ametop: a randomized clinical trial., Otol. Neurotol., 2008, 29, 5, 658-660, doi: 10.1097/MAO.0b013e3181776749.

Additional files

Editorial Notes