Thalin 1985.
| Methods |
Randomised ‐ yes, block randomisation, method of random sequence generation not described Concealment of allocation ‐ adequate Double‐blind ‐ yes Intention‐to‐treat (ITT) ‐ unclear Loss to follow‐up ‐ described Design ‐ parallel |
|
| Participants |
N ‐ 293 children (N = 293 children included in analysis) Age ‐ between 2 and 15 years Setting ‐ secondary care: department of otorhinolaryngology in Halmstad (Sweden) Inclusion criteria ‐ purulent acute otitis media (AOM) (no further criteria described) Exclusion criteria ‐ antibiotic treatment or AOM episode < 4 weeks prior to randomisation, suspected penicillin allergy, presence of ventilation tubes, sensorineural hearing loss, existence of concomitant infection for which antibiotic treatment was required and chronic diseases Baseline characteristics ‐ not described |
|
| Interventions | Tx ‐ phenoxymethyl penicillin 50 mg/kg/day twice daily for 7 days; N = 159 (N = 159 included in analysis) C ‐ matching placebo in 2 doses for 7 days; N = 158 (N = 158 included in analysis) Use of additional medication ‐ all children were given nose drops containing oxymetazoline chloride and, if needed, analgesics (paracetamol) | |
| Outcomes |
Primary outcome ‐ treatment failure (defined as remaining non‐negligible symptoms such as pain and fever, insufficient resolution of infectious signs during treatment period of 7 days, or both Secondary outcomes ‐ (a) resolution of symptoms over time; (b) AOM relapses; (c) tympanometry, audiometry, or both, results at 4 weeks The children were examined at day 0, days 3 to 4, days 8 to 10 and at 4 weeks Parents were instructed to record symptoms (i.e. temperature, otalgia, discharge from ear and consumption of supplied symptomatic drugs) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Block randomisation, method of random sequence generation not described |
| Allocation concealment (selection bias) | Low risk | Randomisation list was kept by the clinical pharmacologist of the hospital and not disclosed to the investigators until the clinical trial was completed |
| Other bias | Unclear risk | ITT analysis ‐ unclear; baseline characteristics ‐ not described |
| Blinding of participants and personnel (performance bias) | Low risk | Placebo with same taste and appearance as penicillin |
| Incomplete outcome data (attrition bias) | Low risk | No children lost to follow‐up for primary analysis |