Grommet/ventilation tube insertion in adults with otitis media with effusion (glue ear). MedDRA version: 9.1 Level: LLT Classification code 10024759 Term: Local anaesthetic
Conditions
Interventions
Trade Name: EMLA cream 5%
Product Name: EMLA
Pharmaceutical Form: Cream
Trade Name: Xylocaine
Product Name: Xylocaine
Pharmaceutical Form: Cutaneous spray, solution
Sponsors
Whipps Cross University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: English speaking patients - as many of our patients speak poor English; they must be able to understand the procedure and the trial to give informed consent. Aged 18 years or over - as paediatric patients usually require a general anaesthetic for ventilation tube insertion due to poor compliance with lying still. Bilateral otitis media with effusion requiring treatment with ventilation tubes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Limited/no English - as will be unable to give informed consent. Under 18 years of age - unable to comply with lying still. Significant tympanic membrane (eardrum) retraction - ventilation tube insertion is more difficult and may well be more uncomfortable in these patients. Patients requiring examination of their post-nasal space - sometimes required to exclude other causes of OME, and if not performed in the outpatient setting would require general anaesthesia. Tympanic membrane perforation (hole in the eardrum) - would let the local anaesthetic through the eardrum and enter the middle ear with potential for unwanted adverse effects. Significant ear canal stenosis (narrowing) - makes insertion of ventilation tubes more difficult and therefore more uncomfortable for patient. Known allergy to lidocaine/EMLA components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the most effective and acceptable method of locally anaesthetising the tympanic membrane to allow insertion of ventilation tubes in an awake patient, by comparing 10% lidocaine solution with EMLA cream.;Secondary Objective: ;Primary end point(s): Insertion of ventilation tubes under local anaesthetic. Follow-up appontment after 3 weeks. Main outcome measure is patient discomfort, as assessed by a Visual Analogue Scale. | — |
Countries
United Kingdom
Outcome results
None listed