In children, obstruction of the ear canal with cerumen can make visualization of the tympanic membrane difficult, if not impossible. This can cause a significant problem with the examination of children with febrile illnesses. In addition, cerumen impaction can cause ear canal irritation and hearing loss. Various methods are used to remove cerumen, including irrigation, suction, and manual removal with a curette. Several studies have assessed the effectiveness of softening the cerumen with agents such as olive oil, sodium bicarbonate, docusate sodium, para dichlorobenzene, hydrogen peroxide, and triethanolamine polypeptide. Most of these studies were limited by lack of a comparison group or by enrolling only a few children. Whatley and colleagues evaluated the efficacy of docusate sodium, triethanolamine polypeptide, and normal saline as a control, with or without irrigation, in removing cerumen obstruction in children.
The study was a randomized, controlled, double-blind trial of pediatric patients with cerumen obstruction. The participants were children six months to five years of age who were seen in an urban tertiary care emergency department or a large general pediatric clinic. Obstruction of the ear canal with cerumen was identified as partial or complete by one of the four investigators. The children were randomized to receive 1 mL of docusate sodium, triethanolamine polypeptide, or normal saline in the ear canal. If the physician was unable to completely visualize the tympanic membrane 15 minutes later, the ear was irrigated with 50 mL of tepid water. This step was repeated if the membrane was still obstructed. The main outcome measurement was the proportion of tympanic membranes that were completely visualized after the initial treatment or after irrigation.
There were 92 patients enrolled in the study, with a mean age of 35 months. The three treatment groups were similar with regard to age, race, sex, ear enrolled, wax consistency (soft, hard, or mixed), and degree of obstruction. Complete visualization of the tympanic membrane was achieved after treatment in 53 percent of children treated with docusate sodium, 43 percent of children treated with triethanolamine polypeptide, and 68 percent of children treated with normal saline. These results were not significantly different.
There was no difference in response rates when the study site or the investigators were compared. The only trend noted was a higher success rate if the cerumen was considered to be soft rather than hard or mixed. The only adverse event recorded was minor ear canal bleeding after irrigation in one child.
The authors conclude that the use of docusate sodium or triethanolamine polypeptide, compared with the use of normal saline, does not increase the likelihood of visualizing tympanic membranes that were obstructed with cerumen. They add that, despite recent recommendations for the use of docusate sodium before ear irrigation, their findings suggest that this agent is no more effective than saline in children six months to five years of age.