A comparison of the efficacy of 10% lidocaine solution and EMLA cream as local anaesthetic for the insertion of tympanic membrane ventilation tubes. - 10% lidocaine and EMLA cream as LA for insertion of grommets

• Conditions: Grommet/ventilation tube insertion in adults with otitis media with effusion (glue ear).; MedDRA version: 9.1Level: LLTClassification code 10024759Term: Local anaesthetic

• Registration Number: EUCTR2007-000166-21-GB
• Lead Sponsor: Whipps Cross University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified