Optimising local anaesthesia for grommet insertion
| ISRCTN | ISRCTN82643736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82643736 |
| Secondary identifying numbers | N0226132778 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr A E Camilleri
Scientific
Scientific
Clinical Director and Consultant ENT surgeon
University Hospital of South Manchester Foundation Trust
Alexandra BMI Hospital
University of Manchester
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 217 3734 |
|---|---|
| andrew.camilleri@uhsm.nhs.uk |
Study information
| Study design | Double blind randomised controlled 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 | |
| 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(s) | Provided by South Manchester Research Ethics Committee |
| Condition | Ear, Nose and Throat: Grommet insertions |
| Intervention | EMLA (Eutectic mixture of local anaesthetics) or Ametop (topical amethocaine) for grommet insertion |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | mixture of local anaesthetics or topical amethocaine |
| Primary outcome measure | Measuring pain on visual analogue score |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/11/2003 |
| Overall study end date | 15/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 40 |
| Participant inclusion criteria | 40 patients over 18 years of age requiring grommet insertion under local anaesthetic |
| 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
- England
- United Kingdom
Study participating centre
Clinical Director and Consultant ENT surgeon
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | Yes | No |
