Hearing Loss, Otitis Media With Effusion in Children
Conditions
Keywords
Otitis Media with Effusion, Hearing Loss, Children, Middle ear Ventilation
Brief summary
The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear. The main question it aims to answer is: Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion. The Participants will: 1. Have their hearing evaluated before surgery 2. Undergo either myringotomy with ventilation tube insertion or myringotomy alone 3. Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively
Interventions
PROCEDUREMyringotomy with ventilation tube
Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. A tympanostomy tube (Shepard tube) of appropriate size was placed in the incision and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.
PROCEDUREMyringotomy alone
Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. NO FURTHER PROCEDURE WAS DONE and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.
Sponsors
Allama Iqbal Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* cases of otitis media with effusion * more than 20 decibel (dB) conductive hearing loss on pure tone audiometry * non-responder to medical treatment after three months of medical treatment
Exclusion criteria
* Children having recurrent otitis media * Discharging ears * History of bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in hearing | Before and Three months post operatively | The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Improvement in hearing level was labelled if there was decrease in hearing loss of 25% from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Loss (dB) | Before and Three months post operatively | All patients underwent pure tone audiometry for assessment of hearing loss (dB) |
| Degree of Hearing Loss | Before and Three months post operatively | The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Degree of hearing loss was labelled as mild (20-40 dB), moderate (40-60 dB) and severe (60-80 dB). |
Countries
Pakistan
Outcome results
None listed