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Evaluation of the safety and efficacy of manual removal and irrigation in cerumen removal in children

Evaluation of the safety and efficacy of manual removal and irrigation in cerumen removal in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102891
Enrollment
Unknown
Registered
2025-05-21
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Cerumen obstruction

Interventions

Manual removal group:None
Irrigation group:None

Sponsors

Children’s Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Aged 6 months to 18 years old. (2) cerumen obstruction >=25% [14]. (3) Before cerumen removal, the ear canal and eardrum have no abnormal changes, such as inflammation, trauma, structural deformities, etc. (4) Guardians agreed to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Acute and chronic ear inflammation, mastoiditis. (2) Injury of the tympanic membrane and ear canal, ear canal neoplasm, and moderate or severe stenosis of the ear canal. (3) Ear canal or middle ear surgery. (4) Blood scab, external auditory canal foreign body, applying ointment or ear drops in ear canal. (5) Known or suspected allergic reaction to cerumenolytic agents or use of cerumenolytic agents within 1 week before the study. (6) Children with coagulopathy or those taking antiplatelet or anticoagulant drugs. (7) Children with mental retardation, autism, hyperactivity, and other disorders that may affect the degree of cooperation. (8) Children with failed cerumen removal at home or other hospitals.

Design outcomes

Primary

MeasureTime frame
Success rates ;Take the time;Degree of parental cooperation;Adverse reactions;Experience of children;Overall evaluation;Pain score;

Countries

China

Contacts

Public ContactLing Ding

Children’s Hospital of Chongqing Medical University

1020145466@qq.com+86 136 7768 1640

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026