Is phenol more efficient than Ametop for the insertion of grommets (1)

• Research type

  Research Study

• Full title

  Is phenol more efficient than Ametop for the insertion of local anaesthetic grommets in adults? A randomised control trial.

• IRAS ID

  15345

• Contact name

  Miss A Soni-Jaiswal

• Sponsor organisation

  University Hospital of South Manchester NHS Foundation Trust

• Eudract number

  2009-011210-23

• ISRCTN Number

  Not yet applied for

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Grommets are small plastic tubes used to ventilate the middle ear in a variety of ear disorders. In adults, they are commonly inserted into the eardrum (tympanic membrane) with the patient awake, i.e. under local anaesthetic. A number of different local anaesthetics are commonly used by ENT surgeons in the United Kingdom, although little evidence exists looking at their pain profile and long-term complications. In this study we aim to compare the local anaesthetic properties of 'phenol' with 'ametop' to see which one the patients prefer. We will also follow the patients up for twelve months post-procedure to assess any long-term complications. We hope to improve ENT surgical practice within the NHS by doing so. Adult patients requiring routine grommets will be recruited from the ENT clinics at South Manchester Teaching Hospitals and with their consent be randomised into the two arms of this study. One arm will receive phenol local anaesthesia and the second arm will receive ametop anaesthesia. Ten minutes after the surgery, the patients will complete a pain visual analogue score. Both arms will be followed up until the grommets fall out and the residual ear drum perforation heals. Twelve months after the surgery, all patients in the study will undergo a routine hearing test and out-patients review. The study participants will be blinded as to which anaesthetic they receive. The results will then be statistically analysed for any differences in pain and complication rate between the two arms. The study participants will not undergo extra procedures or out-patient visits as a consequence of this trial.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/16

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion