Cerumen impaction Ear, Nose and Throat Impacted cerumen
Conditions
Interventions
After obtaining written informed consent, children were randomized to one of four treatment groups:
1. Irrigation using a 60-ml syringe with attached angiocath tubing
2
l syringe coupled by Luer lock to a 23-gauge angiocath tubing cut off at 1.5 centimeters (cm). The needle and excess tubing were discarded. This length was chosen for safety because the average length
Sponsors
University of Pittsburgh Institutional Review Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Attended Children’s Hospital of Pittsburgh Primary Care Center between June and August 2016 2. Health or sick 3. Aged 6 months to 6 years 4. Cerumen occluding =25% of at least one tympanic membrane by otoscopy
Exclusion criteria
Exclusion criteria: 1. Otorrhea 2. Uses hearing aids 3. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the reduction in cerumen occlusion. A clinician, blinded to the treatment assignment, characterized the wax and determined the percent cerumen occlusion before and after cleaning. We categorized cerumen occlusion into 5 categories: 0%, 1-24%, 25-49%, 50-74%, 75-99%, and 100%. Successful cerumen removal was defined as =24% occlusion after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time until completion 2. Number of personnel and level of training required to complete the procedure. We recorded the number of personnel and level of training (parents, students, medical assistants, nurses, and physicians) required to position the child, complete the procedure, and perform cleanup. 3. Parental satisfaction. After the procedure, we queried the parents, using a 10-point scale, how scary the experience was for their child, how painful the experience was for their child, how their child tolerated the experience, if they would want this procedure done again, how easy the experience was, how they felt about the time it took, and how satisfied they were with their experience. | — |
Countries
United States of America
Outcome results
None listed