Surgery for otitis media in Indigenous Australian children

This will be a multi-centre randomised (allocation concealed) trial of the effects of two surgical interventions in the management of Otitis Media with effusion (OME) / recurrent Acute Otitis Media (rAOM) with the primary outcome determined by a blinded assessor. Aboriginal and Torres Strait Islander children, and non-Indigenous children from the same communities, between the ages of 3-10 years of age will be randomized into 3 groups according to age, sex, and desert or tropical dweller: 1. adenoidectomy with ventilation tubes (VTA) 2. adenoidectomy with myringotomy (MA) 3. medical treatment as clinically indicated All 3 treatments are currently acceptable for this condition. The study will test whether there is an advantage of VTA or MA over medical therapy in controlling OME/rAOM. Only children who have been referred to ENT clinics for treatment of chronic OM will be eligible for recruitment. The children will be treated using one of these 3 interventions whether they participate in the trial or not. The difference will be the choice of treatment by the surgeon (non-participants) or by computer allocation (participants). The surgical interventions may take up to 30 minutes per child. The surgery will occur once per child only. Children allocated to the medical intervention may be given surgical treatment after 12 months if deemed necessary by the ENT specialist. TREATMENT PROTOCOLS Adenoidectomy will be performed under direct vision utilizing a suction diathermy or curette technique followed by five days of the oral antibiotic, amoxycillin (or cotrimoxazole if allergic to penicillin) to reduce the risk of postoperative infection, bleeding and halitosis. Adenoidal tissue will be biopsied for culture and histopathological analysis. Ventilation tube insertion will be of a standardized tube (Shephard’s) in the anterior inferior segment of the tympanic membrane after aspiration of the middle ear fluid. All children having ventilation tubes will be prescribed post-operative Ciprofloxacin ear drops (Ciloxan / registered trademark) with three drops three times a day for three days to reduce post operative otorrhoea and blockage of the tube. Myringotomy alone will be a small radial incision to the anterior inferior segment of the tympanic membrane with suction of middle ear fluid. The parents/carers will be counselled to seek medical attention if there are signs of secondary haemorrhage from the adenoid region. Paracetamol or similar analgesia (rather than non-steroidal medications) will be prescribed post operatively. Children allocated to the medical control arm will have already failed “standard medical care”. These children will receive additional specialist attention. This will include advice (written and verbal information with an interpreter if required) about the management of hearing and effective communication strategies and further antibiotic treatment (if appropriate). Referral to audiological services will ensure that children with more significant conductive hearing loss receive appropriate hearing support in the 12 months after randomisation. All children will be followed up with monthly phone calls to the Community Health Worker who will determine and report the presence or absence of aural discharge. All children will be followed up by the study staff visiting them in the community for full audiometric / tympanometry / video-otoscopy assessment at 12 months post op.