Ceruminolytic efficacy of 2.5% Sodium bicarbonate and Docusate sodium in patient with impacted cerumen. A Randomized, Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20160803001

Enrollment

114

Registered

2016-08-03

Start date

2016-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ceruminolytic efficacy of Sodium bicarbonate and Docusate sodium Side effect of Sodium bicarbonate and Docusate sodium ear drop Ceruminolytic Ceruminolytic efficacy Sodium bicarbonate Docusate sodium impacted cerumen

Interventions

One group of patient with impacted cerumen will receive intra&#45

aural instillation of 2.5% Sodium bicarbonate ear drop for 15 minuates. Physician clean the ear canal and record the result which is the time use to clean until completely seen Tympanic membrane. If u

patient will be applied the same ceruminolytics for 15 minuate and cleaned the ear canal again.,another group of patient with impacted cerumen will receive intra&#45

aural instillation of Docusate sodium ear drop for 15 minuates. Physician clean the ear canal and record the result which is the time use to clean until completely seen Tympanic membrane. If unsuccess

patient will be applied the same ceruminolytics for 15 minuate and cleaned the ear canal again.

Experimental Drug,Experimental Drug

applying 2.5% Sodium bicarbonate ear drop,applying Docusate sodium ear drop

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patient age is 18-85 years old Patient is diagnosed as complete impacted cerumen after 1st cleaning with suction or forcep

Exclusion criteria

Exclusion criteria: Small ear canal (cannot apply ear speculum diameter 4 mm.) History of canalopasty /canal wall down or radical mastoidectomy Received ceruminolytic 1 week before Acute or chronic otitis externa Cannot answer the questionnaire or incooperative to the operation Allergy to the study agents (Docusate sodium or 2.5%Sodium bicarbonate)

Design outcomes

Primary

Measure	Time frame
Visualization of Tympanic membrane after applied ceruminolytic and ear cleaning completely visualized Tympanic membrane recorded by 2 physicians	—

Secondary

Measure	Time frame
side effect of ceruminolytics after applied ceruminolytic and ear cleaning questionnaire	—

Countries

Thailand

Contacts

Public ContactChanticha Laohakittikul

Khon Kaen university

L.chanticha@gmail.com0841293438

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Ceruminolytic efficacy of 2.5% Sodium bicarbonate and Docusate sodium in patient with impacted cerumen. A Randomized&#44; Controlled Trial