Management of post-strabismus nausea and vomiting in children using ondansetron: a value-based comparison of outcomes.
BACKGROUND
This study evaluated the clinical efficacy and cost-effectiveness of prophylactic ondansetron versus early ondansetron treatment in the management of postoperative nausea and vomiting (PONV) in children undergoing strabismus repair using clinically meaningful outcomes and value-based principles.


METHODS
One hundred and fifty children were randomly assigned to either prophylactic (P) or early symptomatic treatment only (T) group (n = 75). Children in group P received ondansetron 100 micrograms kg-1 i.v. and those in group T received placebo at the end of the procedure. After surgery, at the earliest sign of nausea or vomiting, children in both groups received ondansetron 100 micrograms kg-1 i.v. Besides the incidence of PONV, non-surrogate (fast tracking time, duration of stay in the postanaesthesia care unit (PACU) and parental satisfaction scores), therapeutic (numbers needed to prevent and treat) and pharmacoeconomic (cost to benefit a child and cost per PONV-free child) outcome measures were evaluated.


RESULTS
The incidences of PONV in the immediate, early, late and first 24-h periods were significantly less in group P (20, 12, 19 and 35% respectively) than in group T (37, 29, 47 and 72%, P < 0.05). Time to achieve fast-track eligibility and duration of PACU stay were significantly shorter in group P (P < 0.001). Children in group P had superior mean (SD) parental satisfaction scores (8.2 (1.8)) compared with those in group T (6.8 (1.7), P < 0.001). The number needed to prevent PONV was 2 and the number needed to treat PONV was 9. The cost to benefit a child was more than fourfold less and the cost per PONV-free child was 35% less in group P.


CONCLUSIONS
Compared with early symptomatic treatment with ondansetron, prophylactic ondansetron shortened fast-tracking time and duration of PACU stay and improved parental satisfaction and therapeutic outcomes at a lower direct cost.
Sennaraj
B
B
All India Institute of Medical Sciences, New Delhi, India.
Shende
D
D
Sadhasivam
S
S
Ilavajady
S
S
Jagan
D
D
D000293:Adolescent; D000932:Antiemetics / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D017294:Ondansetron / Q000191:economics / Q000627:therapeutic use*; D017060:Patient Satisfaction; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D013285:Strabismus / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome
D000932:Antiemetics; D017294:Ondansetron