Optimising local anaesthesia for grommet insertion
| ISRCTN | ISRCTN82643736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82643736 |
| Protocol serial number | N0226132778 |
| Sponsor | Department of Health |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | mixture of local anaesthetics or topical amethocaine |
| Primary outcome measure(s) |
Measuring pain on visual analogue score |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | 40 patients over 18 years of age requiring grommet insertion under local anaesthetic |
| Key exclusion criteria | Added 19/10/09: children and adult patients not willing to sign consent form. |
| Date of first enrolment | 15/11/2003 |
| Date of final enrolment | 15/11/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Director and Consultant ENT surgeon
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
