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Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children
Valerie N Whatley1, Carey L Dodds, Ronald I Paul
1Department of Pediatrics, Divisions of Pediatric Emergency Medicine and Ambulatory Medicine, University of Louisville, Louisville, KY 40202, USA. vnwhat01@louisville.edu
Insights
Docusate sodium and triethanolamine polypeptide did not improve visualization of the tympanic membrane in children compared to saline. Saline was equally effective for cerumen removal in pediatric patients.
Area of Science:
- Otolaryngology
- Pediatric Medicine
- Pharmacology
Background:
- Cerumen impaction frequently obstructs otoscopic examination in children.
- Effective cerumen removal is crucial for accurate diagnosis and treatment.
Purpose of the Study:
- To compare the efficacy of docusate sodium, triethanolamine polypeptide, and saline in relieving pediatric cerumen obstruction.
- To determine if specific cerumenolytic agents offer advantages over saline control.
Main Methods:
- A randomized, double-blind trial involving pediatric patients (6 months-5 years) with cerumen obstruction.
- Administration of docusate sodium, triethanolamine polypeptide, or saline, followed by optional irrigation.
- Primary outcome: proportion of completely visualized tympanic membranes.
Main Results:
- No significant difference in tympanic membrane visualization between docusate sodium (53%), triethanolamine polypeptide (43%), and saline (68%) groups (P =.17).
- Patient groups were comparable in age, sex, race, ear enrolled, wax consistency, and obstruction severity.
Conclusions:
- Docusate sodium and triethanolamine polypeptide were not significantly more effective than saline for cerumen removal in children.
- Saline serves as an effective and comparable control agent for pediatric cerumen obstruction.
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.