Flubacher P, Fournier N, Cherpillod J et al.
Anaesthesia 2017; 72: 859–863
DOI: 10.1111/anae.13907
Aim of study
Tested the hypothesis that droperidol or ondansetron, in combination with a moderate dose of dexamethasone were equally effective in reducing nausea and vomiting after tonsillectomy in children and that both were superior to dexamethasone alone.
Design and location
Randomised, double blind trial. (Switzerland)
Methodology
Random assignment to one of three study groups (plan to enrol at least 100 children to each group); placebo + dexamethasone, droperidol + dexamethasone, ondansetron + dexamethasone.
Pharmacy prepared syringes formulated to give the study drug in ml.kg-1.
All given the same form of anaesthetic (induction and maintenance) adjusted for weight.
Surgical procedure performed using electric bipolar forceps.
Primary outcome
Rate of post-op nausea and vomiting within the 24 hours. (after phoning parents at home).
Secondary outcomes
Rates of vomiting, nausea and vomiting and rescue anti-emesis in the recovery room.
Rates of nausea and vomiting after discharge.
Rates of hospitalisation and re-admission.
Rates of tonsillar haemorrhage.
In addition the rates of headache, extrapyramidal syndrome or drowsiness and dose of i.v morphine given in recovery were recorded.
Statistics
Students T-test or ANOVA to compare means.
Pearson’s chi-squared or Fishers exact test to compare rates.
Cloppers –Pearson exact method to calculate their confidence intervals.
P< 0.05 considered significant.
Results
Analysed data from 262 /300 children recruited.
Rates of nausea and vomiting within 24 hours was: 46% with saline + Dexamethasone, 49% with droperidol + dexamethasone, 21% with ondansetron and dexamethasone. P< 0.001.
Rates of headache: saline 6%, droperidol 9%, ondansetron 2%. P=0.16.
Rates of extrapyramidal symptoms: saline 1/91, droperidol 2/87, ondansetron 1/84. P=0.77.
Back to theatre for haemostasis before discharge: 1 post droperidol, 1post ondansetron.
Readmissions for nausea and vomiting: 1/91 saline, 2/87 for droperidol, 2/84 ondansetron.
Conclusions:
Ondansetron is more effective than saline in preventing nausea and vomiting post tonsillectomy in children when given with a moderate dose of dexamethasone.
An additive anti-emetic effect with droperidol was not detected.
There were no differences in the rates of side-effects between groups.
Stated study limitations
Dexamethasone may have antagonised the independent anti-emetic effect of droperidol and ondansetron.
Don’t know the rates of nausea and vomiting beyond 24 hours post op.
Discussion from journal club meeting
No standardised fluid regimen stated in the study.
Summary by Dr K. Turley. Journal Club 14 September 2017.
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