Objectives

To determine the effectiveness of ciprofloxacin 0.3% antibiotic eardrops in preventing clinically significant postoperative otorrhoea and tube obstruction following grommet insertion in children.

Design

3-arm parallel assessor-blinded randomised controlled trial. Randomisation in 1:1:1 ratio to single intraoperative application of ciprofloxacin drops, extended 5-day postoperative application and no drops. Patients were assessed by blinded assessors at 6 weeks postoperatively.

Setting

The study was conducted in a large tertiary health network in Melbourne, Australia.

Participants

All children, 17 years and under, undergoing bilateral MEVT surgery with or without concurrent upper airway surgery for recurrent acute otitis media and chronic otitis media with effusion were approached.

Main Outcome Measures

Presence of postoperative otorrhoea and ventilation tube obstruction at 6 weeks postoperatively.

Results

256 paediatric patients completed the study with a median age of 4.02 years. 153 participants were male. By ear-analysis (n=512) showed intraoperative antibiotics were more effective than no drops in preventing otorrhoea (RR=0.341, 95%CI 0.158–0.738, NNT= 11.25, p=.006). Postoperative antibiotics were more effective than no drops in preventing ventilation tube obstruction (RR=0.424, 95%CI 0.193 to 0.930, NNT=14.7 p=.032).

Conclusion

Intraoperative topical ciprofloxacin was effective at preventing early postoperative otorrhoea and a prolonged course was effective at preventing ventilation tube obstruction. Future studies on this topic should seek to clarify whether particular subgroups of patients benefit more from prophylactic topical antibiotics and model for cost-effectiveness.