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

BACKGROUND: Cerumen obstructing visualization of the tympanic membrane in children is a common and frustrating problem. Docusate sodium, triethanolamine polypeptide, and saline were compared to determine their effectiveness in relieving cerumen obstruction in children.
METHODS: A randomized, controlled, double-blind trial was performed on pediatric patients aged 6 months through 5 years with cerumen obstruction. The enrolling physician determined whether the cerumen completely or partially obstructed visualization of the tympanic membrane. One milliliter of docusate sodium, triethanolamine polypeptide, or normal saline as control was placed into the patient's ear canal. If the tympanic membrane was not completely visualized after 15 minutes, the ear was irrigated with 50 mL of tepid water. Irrigation was repeated a second time if needed. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumeno-eblytic agents or control saline, alone or with irrigation if needed.
RESULTS: Of 92 patients enrolled, 34 received docusate sodium; 30, triethanolamine polypeptide; and 28, saline. Mean +/- SD patient age was 34.7 +/- 18.1 months, and 50 (54%) of the patients were girls. Groups were similar in age, race, sex, ear enrolled, wax consistency, and degree of obstruction. There was no significant difference in the proportion of tympanic membranes completely visualized after treatment with docusate (18/34; 53%), triethanolamine polypeptide (13/30; 43%), or saline (19/28; 68%) (P =.17).
CONCLUSION: Application of docusate sodium or triethanolamine polypeptide did not significantly improve the proportion of tympanic membranes that were completely visualized vs application of the saline control.

RCT Entities:   Population Interventions Outcomes