Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children

Abstract

Context The efficacy of the variety of ceruminolytic agents used in clinical practice in children is not very well studied. Objectives To evaluate the efficacy of triethanolamine polypeptide and docusate as ceruminolytic agents in children with cerumen impaction. Design Randomized controlled trial. Setting Urban tertiary care children's hospital emergency department and general pediatric clinic. Participants 92 children aged 6 months to 5 years who presented as a convenience sample to either of the study sites with cerumen impaction. Intervention Children were computer randomized to receive 1-mL instillation of triethanolamine polypeptide, docusate, or saline placebo. The study drug was left in place for 15 minutes, then flushed with a standardized amount and technique of warm tap water up to two times. Main outcome measures Percentage of children in each group that had complete visualization of the tympanic membrane (light reflex, ossicles, and mobility). Results Groups were similar in age, race, sex, ear enrolled, wax consistency, and degree of obstruction. There was no statistical difference in the percentage of children who had complete resolution of cerumen impaction (docusate 53%, triethanolamine polypeptide 43%, and placebo 68%). Conclusion There was no difference between either of the two drugs used or placebo in alleviating cerumen impaction in children. Comment Earache is the fourth most common complaint of children who present to a pediatrician. The diagnosis of the various ear disorders requires careful history and examination of the ear canal and tympanic membrane. All too often, the pediatrician is frustrated by the inability to adequately examine the ear due to cerumen impaction. There are several studies of the agents used commonly in practice to alleviate cerumen obstruction,1.Jaffe G. Grimshaw J. A multicentric clinical trial comparing Otocerol® with Cerumol® as cerumenolytics.J Int Med Res. 1978; 6: 241-244Crossref PubMed Scopus (13) Google Scholar, 2.Fahmy S. Whitefield M. Multicentre clinical trial of Exterol® as a cerumenolytic.Br J Clin Pract. 1982; 36: 197-204PubMed Google Scholar, 3.Keane E.M. Wilson H. McGrane D. Coakley D. Walsh J.B. Use of solvents to disperse ear wax.Br J Clin Pract. 1995; 49: 7-12PubMed Google Scholar, 4.Lyndon S. Roy P. Grillage M.G. Miller A.J. A comparison of the efficacy of two ear drop preparations (Audax® and Earex®) in the softening and removal of impacted ear wax.Curr Med Res Opin. 1992; 13: 21-25Crossref PubMed Scopus (19) Google Scholar, 5.Meehan P. Isenhour J.L. Reeves R. Wrenn K. Ceruminolysis in the pediatric patient: a prospective, double-blinded, randomized controlled trial.Acad Emerg Med. 2002; 9: 521-522Crossref Google Scholar, 6.Singer A.J. Sauris E. Viccellio A.W. Ceruminolytic effects of docusate sodium: a randomized, controlled trial.Ann Emerg Med. 2000; 36: 228-232Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar but they include very few children. There is even a meta-analysis on the topic7.Burton M.J. Doree C.J. Ear drops for the removal of ear wax.The Cochrane Database of Systematic Reviews. 2003; Vol 1Google Scholar that shows heterogeneous effects based on the studies of low quality that existed before this study. This study sought to identify any differences in efficacy of the most commonly used agents, docusate, and triethanolamine polypeptide (Cerumenex). Their study design was sound, but found no difference between the two drugs studied, and even had a trend toward the saline control being more effective. Unfortunately, it was relatively underpowered with an 80% chance of finding a 40% difference between groups. Perhaps pediatricians would be happy deciding between the two alternatives if only a 10% to 20% difference existed. Detecting this difference would have required a much larger sample size to achieve (>300 in each group). In the meantime, pediatricians are left with their clinical judgment and experience in selecting from the variety of agents and procedures to clear ear wax for a good view.