Grandis 1992.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled study conducted in USA Grading of quality: Randomisation = C Blinding = A Intention‐to‐treat analysis =C Follow‐up = D Overall quality grading = C |
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Participants | 198 adults and children aged 12 to 48 (mean 21.7) years undergoing tonsillectomy or adenotonsillectomy (indication not specified). Study and control groups were well matched with regard to age, sex and adenoidectomy (18 versus 14 respectively). Exclusion criteria: antibiotic administered within 1 week preoperatively, medical condition requiring perioperative antibiotic therapy, or allergy to antibiotic studied |
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Interventions | Ticarcillin + clavulanic acid, IV 3.1 g at completion of surgery, 6 and 12 hours after surgery; followed by amoxicillin + clavulanic acid 250 mg tds oral for 7 days | |
Outcomes | Primary outcomes: pain (scale of 1 to 10, 10 being most severe) and consumption of analgesics Secondary outcomes: fever (temperature > 99.9 °F) and return to regular diet (scale of 1 to 3; 1 = regular, 2 = soft, 3 = liquid) and activities (1 = normal, 2 = moderate, 3 = bed rest) Period of observation: 7 days |
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Notes | Anaesthetic and surgical techniques not mentioned as being controlled Follow‐up: only 101 (51%) patients (51 in antibiotic and 50 in control groups) completed follow‐up |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |