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Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes.
Ann Otol Rhinol Laryngol 2019; 128(8):760-766AO

Abstract

OBJECTIVE

The objectives of this study are to evaluate incidence, duration, and quality of life (QOL) impact of early tympanostomy tube otorrhea and tube patency when comparing topical ciprofloxacin versus normal saline use in the perioperative period.

METHODS

Overall, 200 patients undergoing tube placement between November 19, 2015, and September 12, 2016, were randomized to intraoperative plus 5 days of either topical ciprofloxacin or normal saline. Parents or caregivers reported the incidence, duration, and QOL impact of early otorrhea via 4 weekly surveys. In addition, the patient's otorrhea history and tube patency were evaluated at a 4- to 6-week postoperative visit.

RESULTS

Survey and in-office follow-ups were completed on 128 patients. The overall otorrhea incidence was 23.9% for normal saline and 16.7% for ciprofloxacin (P = .32). The week-by-week otorrhea incidence was not statistically different. The percentage of days otorrhea was present, likewise, was not statistically different (normal saline 4.5%, ciprofloxacin 2.8%; P = .74). The QOL impact was not statistically different (normal saline 1.2, ciprofloxacin 1.5; P = .71). Tube patency was not statistically different, with only 1 of 280 ears occluded at follow-up.

CONCLUSION

We find no difference in the incidence, duration, and QOL impact of early tympanostomy tube otorrhea or tube patency between ciprofloxacin and normal saline. This supports the option to substitute normal saline for ciprofloxacin in ears without an active ear infection at the time of tube placement, which would reduce both cost and unnecessary antibiotic use.

LEVEL OF EVIDENCE

1b.

Authors+Show Affiliations

1 Cleveland Clinic Otolaryngology, Cleveland, OH, USA.2 Cleveland Clinic, Lerner College of Medicine, Cleveland, OH, USA.2 Cleveland Clinic, Lerner College of Medicine, Cleveland, OH, USA.1 Cleveland Clinic Otolaryngology, Cleveland, OH, USA.1 Cleveland Clinic Otolaryngology, Cleveland, OH, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30991815

Citation

Gabarain, Gabriel, et al. "Early Otorrhea Rates: a Randomized Trial of Ciprofloxacin Versus Saline Drops After Tympanostomy Tubes." The Annals of Otology, Rhinology, and Laryngology, vol. 128, no. 8, 2019, pp. 760-766.
Gabarain G, Baird R, Morisada M, et al. Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes. Ann Otol Rhinol Laryngol. 2019;128(8):760-766.
Gabarain, G., Baird, R., Morisada, M., Anne, S., & Hopkins, B. (2019). Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes. The Annals of Otology, Rhinology, and Laryngology, 128(8), pp. 760-766. doi:10.1177/0003489419843550.
Gabarain G, et al. Early Otorrhea Rates: a Randomized Trial of Ciprofloxacin Versus Saline Drops After Tympanostomy Tubes. Ann Otol Rhinol Laryngol. 2019;128(8):760-766. PubMed PMID: 30991815.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes. AU - Gabarain,Gabriel, AU - Baird,Rachel, AU - Morisada,Megan, AU - Anne,Samantha, AU - Hopkins,Brandon, Y1 - 2019/04/16/ PY - 2019/4/18/pubmed PY - 2019/7/19/medline PY - 2019/4/18/entrez KW - chronic otitis media KW - conductive hearing loss KW - middle ear KW - otitis media KW - quality of life KW - tympanostomy tube SP - 760 EP - 766 JF - The Annals of otology, rhinology, and laryngology JO - Ann. Otol. Rhinol. Laryngol. VL - 128 IS - 8 N2 - OBJECTIVE: The objectives of this study are to evaluate incidence, duration, and quality of life (QOL) impact of early tympanostomy tube otorrhea and tube patency when comparing topical ciprofloxacin versus normal saline use in the perioperative period. METHODS: Overall, 200 patients undergoing tube placement between November 19, 2015, and September 12, 2016, were randomized to intraoperative plus 5 days of either topical ciprofloxacin or normal saline. Parents or caregivers reported the incidence, duration, and QOL impact of early otorrhea via 4 weekly surveys. In addition, the patient's otorrhea history and tube patency were evaluated at a 4- to 6-week postoperative visit. RESULTS: Survey and in-office follow-ups were completed on 128 patients. The overall otorrhea incidence was 23.9% for normal saline and 16.7% for ciprofloxacin (P = .32). The week-by-week otorrhea incidence was not statistically different. The percentage of days otorrhea was present, likewise, was not statistically different (normal saline 4.5%, ciprofloxacin 2.8%; P = .74). The QOL impact was not statistically different (normal saline 1.2, ciprofloxacin 1.5; P = .71). Tube patency was not statistically different, with only 1 of 280 ears occluded at follow-up. CONCLUSION: We find no difference in the incidence, duration, and QOL impact of early tympanostomy tube otorrhea or tube patency between ciprofloxacin and normal saline. This supports the option to substitute normal saline for ciprofloxacin in ears without an active ear infection at the time of tube placement, which would reduce both cost and unnecessary antibiotic use. LEVEL OF EVIDENCE: 1b. SN - 1943-572X UR - https://www.unboundmedicine.com/medline/citation/30991815/Early_Otorrhea_Rates:_A_Randomized_Trial_of_Ciprofloxacin_versus_Saline_Drops_after_Tympanostomy_Tubes_ L2 - http://journals.sagepub.com/doi/full/10.1177/0003489419843550?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -