Acute otitis media
Conditions
Brief summary
The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates
Detailed description
Secondary outcomes are proportions of children - needing rescue antibiotics - with no improvement of overall condition by the first scheduled control visit (day 2-4) - with no improvement of otoscopic signs (7-9 day visit) - with middle ear effusion at days 2, 7 and 14 - with development of contralateral AOM during the treatment - with spontaneous perforation of the tympanic membrane during the treatment - with side effects (for ex. diarrhea, rash)
Interventions
DRUGSyrsSpend SF pH 4
DRUGAmorion 100 mg/ml jauhe oraalisuspensiota varten
Sponsors
Pohjois-Savon hyvinvointialue
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are proportions of children - needing rescue antibiotics - with no improvement of overall condition by the first scheduled control visit (day 2-4) - with no improvement of otoscopic signs (7-9 day visit) - with middle ear effusion at days 2, 7 and 14 - with development of contralateral AOM during the treatment - with spontaneous perforation of the tympanic membrane during the treatment - with side effects (for ex. diarrhea, rash) | — |
Outcome results
None listed