Objectives: To determine the effectiveness of ciprofloxacin 0.3%
antibiotic eardrops in preventing clinically significant postoperative
otorrhea and tube obstruction following grommet insertion in children.
Design: 3-arm double-blinded randomized controlled trial. Randomisation
in 1:1:1 ratio into two interventional and one control arm. The
interventional groups received either 5 drops of topical ciprofloxacin
0.3% eardrops in each ear intraoperatively or intraoperatively and for
5 days postoperatively. The control group received 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
otorrhea and ventilation tube obstruction at 6 weeks postoperatively.
Results: 256 pediatric patients completed the study with a median age of
4.02 years. 153 participants were male. Intraoperative antibiotics were
more effective than control in preventing otorrhea (RR=0.341, 95%CI
0.158–0.738, NNT= 11.25, p=.006). Postoperative antibiotics were more
effective than control 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 otorrhea 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. Trial Registration: This trial was registered
prospectively on the Australian New Zealand Clinical Trials Registry
(ACTRN12618001082291) on the 28th of June 2018. Available at URL:
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375306
The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial
