Halsted 1968.
Methods |
Randomised ‐ yes, pre‐determined code, which was unknown to physician; method of random sequence generation unclear Concealment of allocation ‐ adequate Double‐blind ‐ yes Intention‐to‐treat (ITT) ‐ unclear Loss to follow‐up ‐ described, unclear from which treatment group patients were excluded Design ‐ parallel |
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Participants |
N ‐ 106 children (N = 89 children included in analysis; N = 12 children were excluded because they did not adhere to the double‐blind protocol; N = 5 children lost to follow‐up or excluded because of persistent fever, development of complication requiring antibiotic treatment or if group A streptococci was cultured from the middle ear) Age ‐ between 2 months and 5.5 years Setting ‐ secondary care: paediatric department of Cleveland (USA) Inclusion criteria ‐ AOM based on otoscopic findings; most of the cases had bulging membrane with loss of normal light reflex and landmarks, in a few the eardrum was only diffusely red Exclusion criteria ‐ antibiotic treatment < 10 days prior to randomisation, associated bacterial infection requiring antibiotic treatment, rupture of tympanic membrane, contraindication for study drugs Baseline characteristics ‐ not described |
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Interventions |
Tx 1 ‐ ampicillin 100 mg/kg/day 4 daily for 10 days; N = ? (N = 30 included in analysis) Tx 2 ‐ pheneticillin 30 mg/kg/day 4 daily and sulfisoxazole 150 mg/kg/day 4 daily for 10 days; N = ? (N = 32 included in analysis) C ‐ placebo for 10 days; N = ? (N = 27 included in analysis) Use of additional medication ‐ phenylephrine nose drops and aspirin for children over 6 months was prescribed as necessary; no other medications were employed |
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Outcomes |
Primary outcome ‐ early improvement defined as defervescence and decrease of symptoms at 24 to 72 hours Secondary outcomes ‐ (a) late improvement defined as resolution of symptoms and normal tympanic membrane at 14 to 18 days, (b) bacteriological cultures |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Pre‐determined code, which was unknown to physician; method of random sequence generation unclear |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Other bias | Unclear risk | ITT analysis ‐ unclear, baseline characteristics ‐ not described |
Blinding of participants and personnel (performance bias) | Unclear risk | Identical taste and appearance to antibiotics and placebo not described |
Incomplete outcome data (attrition bias) | Unclear risk | Reasons described, unclear from which treatment group patients were excluded |