- Design
- single-centre, parallel-design, quadruple-blinded randomised placebo-controlled trial
- Population
- 209 children aged 3 to 17 undergoing adenotonsillectomy (131 completed pain diaries)
- Primary outcome
- mean pre-analgesic pain score on postoperative days 2 to 8
- Effect
- pain 4.12 versus 4.84, difference 0.72 (95% CI 0 to 1.44); opioid prescription odds ratio 0.23 (95% CI 0.06 to 0.84); no increase in haemorrhage
Two hundred and nine children aged 3 to 17 undergoing adenotonsillectomy at a single tertiary centre were randomised, quadruple-blinded, to oral dexamethasone 0.5 mg/kg (maximum 20 mg) or placebo on postoperative days 2, 4 and 6. Pain diaries were followed for 14 days; adverse events to 5 to 9 weeks. One hundred and thirty-one children completed diaries and contributed to the pain analysis; all 209 contributed to safety and utilisation outcomes.
The primary outcome was pre-analgesic pain on days 2 to 8: 4.12 with dexamethasone against 4.84 with placebo, a difference of 0.72 points (95% CI 0 to 1.44). The authors are explicit that the width of that interval and baseline differences in pain before study medication prevent a definitive conclusion. What was clearer sat downstream. Pain was lower on days 12 and 13 (mean differences 0.96 to 2.37 points). The odds of receiving an opioid prescription were 0.23 (95% CI 0.06 to 0.84) and of an emergency department visit for pain 0.12 (95% CI 0.003 to 0.91). Readmissions, nursing calls, post-tonsillectomy haemorrhage and return to normal diet showed no clinically meaningful difference.
The haemorrhage result is what makes this adoptable. The standing objection to steroids after tonsillectomy has always been bleeding risk, and in 209 children there was no signal. Given that, three doses of a cheap oral drug that cut opioid prescriptions to roughly a quarter is worth adding to a discharge protocol even on a modest pain effect.
One caution on the utilisation outcomes: they are secondary, on small event numbers, in a single centre with its own opioid prescribing culture. A unit that already prescribes no opioids after tonsillectomy — which describes much of Indian practice — will not see that benefit. There, the relevant outcome is the day 12 to 13 pain difference and the fewer pain-driven emergency visits.
- Add oral dexamethasone 0.5 mg/kg (maximum 20 mg) on postoperative days 2, 4 and 6 to the adenotonsillectomy discharge protocol
- Reassure parents on bleeding: no increase in post-tonsillectomy haemorrhage was seen in this trial
- Warn that pain around days 5 to 8 remains substantial — this is an adjunct, not a solution
- Keep scheduled paracetamol and ibuprofen as the base regimen rather than replacing them
- Check for varicella or active infection exposure before a repeated steroid course in a child
Don't overread it
The primary pain outcome was inconclusive; the opioid and emergency-visit reductions are secondary findings on small event numbers at one centre.
The statistics, in plain English
The primary outcome's confidence interval, 0 to 1.44 points, touches zero, so the pain difference is not established — the authors say so. The utilisation odds ratios look dramatic but rest on very few events: an interval of 0.003 to 0.91 for emergency visits signals a handful of events, not a precisely measured effect. Only 131 of 209 children returned pain diaries, and diary completion may not be random. What is genuinely reassuring is the absence of a haemorrhage signal across all 209.
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