Little 2001.
| Methods |
Randomised ‐ yes, method of randomisation not described Concealment of allocation ‐ adequate Double‐blind ‐ no; open‐label study, investigators not blinded Intention‐to‐treat (ITT) ‐ yes Loss to follow‐up ‐ described Design ‐ parallel |
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| Participants |
N ‐ 315 children (N = 285 children included in analysis) Age ‐ between 6 months and 10 years Setting ‐ general practice; 42 general practitioners in 3 health authorities in south‐west England Inclusion criteria ‐ acute otalgia and otoscopic evidence of acute inflammation of the eardrum (dullness or cloudiness with erythema, bulging or perforation). When children were too young for otalgia to be specifically documented from their history (under 3 years old) then otoscopic evidence alone was a sufficient entry criterion Exclusion criteria ‐ otoscopic appearances consistent with crying or a fever alone (pink drum alone), appearances and history more suggestive of otitis media with effusion and chronic suppurative otitis media, serious chronic disease (such as cystic fibrosis, valvular heart disease), use of antibiotics < 2 weeks prior to randomisation, previous complications (septic complications, hearing impairment) and if the child was unwell to be left to wait and see (e.g. high fever, floppy, drowsy, not responding to antipyretics) Baseline characteristics ‐ balanced |
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| Interventions | Tx ‐ immediate treatment with antibiotics: amoxicillin syrup 125 mg/5 mL 3 times daily for 7 days (children who were allergic to amoxicillin received erythromycin 125 mg/5 mL 4 times daily; N = 151 (N = 135 included in analysis) C ‐ similar antibiotics were prescribed but parents were asked to wait for 72 hours before considering using the prescription. Parents were instructed that if their child still had substantial otalgia or fever after 72 hours, had discharge for > 10 days or was not starting to get better then they should collect the antibiotic prescription that was left at the practice; N = 164 (N = 150 included in analysis) Use of additional medication ‐ for both groups doctors emphasised the importance of paracetamol in full doses for relief of pain and fever | |
| Outcomes |
Primary outcomes ‐ (a) duration of symptoms (i.e. earache, ear discharge, night disturbance, crying); (b) daily pain score; (c) episodes of distress; (d) spoons of paracetamol used; (e) use of antibiotics Doctors were asked to provide information on days of illness, physical signs and antibiotic prescribing; parents were asked to complete a daily symptom diary |
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| Notes | Open‐label trial comparing immediate versus delayed antibiotic prescription (prescription provided but advised to fill only if symptoms did not improve or worsened) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described |
| Allocation concealment (selection bias) | Low risk | Sealed, numbered, opaque envelopes |
| Other bias | Low risk | ITT analysis ‐ yes, baseline characteristics ‐ balanced |
| Blinding of participants and personnel (performance bias) | Unclear risk | Open‐label trial, outcome assessment not blinded |
| Incomplete outcome data (attrition bias) | Low risk | Loss to follow‐up/exclusion from analysis (intervention ineffective, did not use antibiotics or did not delay) ‐ treatment: N = 16 (12%) and placebo: N = 14 (9%); comparison of the baseline information for the 3 types of responders (those who provided diaries, those who gave information by telephone and those from whom no diary information could be collected) revealed no evidence of significant bias between treatment groups or between patients by age or severity of symptoms |