None listed
Conditions
Brief summary
Research aims: The aims of this trial is to assess the efficacy and rationale for routine topical antibiotic (Ciprofloxacin) for the prevention of grommet obstruction and otorrhoea in grommet surgery (myringotomy and ventilation tube placement) Hypothesis: That a single intraoperative dose of topical ciprofloxacin is as effective as a 5-day postoperative course for prophylaxis of two post-operative complications of paediatric grommet surgery when compared against no prophylaxis. That factors such as age, indication for surgery, number of previous grommets and intraoperative middle ear status are correlated with developing post-operative complications. That there is a significant patient reported quality of life benefit in prophylaxis compared to no prophylaxis. Participants: 360 paediatric patients (17 and under), who are undergoing bilateral myringotomy and ventilation tube placement, with a diagnosis of otitis media with effusion for at least 3 months or recurrent acute otitis media. Methods: 360 participants will be randomised to three groups. (1) Control group, receiving no intervention. (2) Single dose group, receiving one intraoperative dose of topical ciprofloxacin and no postoperative doses. (3) Multi dose group, receiving one intraoperative dose of ciprofloxacin and a 5day postoperative course of topical ciprofloxacin (2 doses daily) Measured outcomes: (1) Incidence of ventilation tube obstruction at 6 weeks diagnosed by otoscopy and tympanometry. (2) Incidence of ventilation tube otorrhoea at 2 weeks and 6 weeks by otoscopy. (3) Difference in validated disease specific QOL(OMO22) at date of surgery and 6 weeks. (4) Difference in audiometry preop and 6 weeks postop.
Interventions
Arm 1: 5 drops of Ciprofloxacin 0.3% topical ear drops intraoperatively (double-blind arm) This is done by a research nurse.
Arm 2: 5 drops of Ciprofloxacin 0.3% topical ear drops intraoperatively + 5 drops of Ciprofloxacin 0.3% topical ear drops twice a day for 5 days postoperatively, given by the parent (assessor-blind arm) Bottles are returned on the postoperative visit. They will also be questioned about their compliance.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
Undergoing bilateral grommet surgery for either: - recurrent acute otitis media (greater than 4 episodes of AOM in 6 months, or greater than 6 in 12 months) - chronic otitis media with effusion (middle ear effusion lasting for more than 3 months)
Exclusion criteria
- allergy to quinolone based antibiotics - recent use of antibiotics (within 7 days of surgery) - failure to gain consent to participate in the study
Outcome results
None listed