Ondansetron (Page 7 of 8)

14.3 Prevention of Further Postoperative Nausea and/or Vomiting

Adu lts

Adult surgical patients receiving general balanced anesthesia (barbiturate: thiopental, methohexital, or thiamylal; opioid: alfentanil or fentanyl; nitrous oxide; neuromuscular blockade: succinylcholine/curare and/or vecuronium or atracurium; and supplemental isoflurane) who received no prophylactic antiemetics and who experienced nausea and/or vomiting within 2 hours postoperatively were evaluated in two double-blind US trials involving 441 patients. Patients who experienced an episode of postoperative nausea and/or vomiting were given Ondansetron Injection (4 mg) intravenously over 2 to 5 minutes, and this was significantly more effective than placebo. The results of these trials are summarized in Table 12.

T able 12. Therapeutic Response in Prevention of Further Postoperative Nausea and/or Vomiting in Adult Patients

Ondansetron4 mgIntravenous

Placebo P- Value
Study 1

Emetic episodes:Number of patients

104 117

Treatment response 24 h after study drug 0 Emetic episodes

49 (47%) 19 (16%) <0.001
1 Emetic episode 12 (12%) 9 (8%)
More than 1 emetic episode/rescued 43 (41%) 89 (76%)
Median time to first emetic episode (min)a 55.0 43.0

Nausea assessments:Number of patients

98

102
Mean nausea score over 24-h postoperative periodb 1.7 3.1
Study 2

Emetic episodes:Number of patients

112 108
Treatment response 24 h after study drug
0 Emetic episodes 49 (44%) 28 (26%) 0.006
1 Emetic episode 14 (13%) 3 (3%)
More than 1 emetic episode/rescued 49 (44%) 77 (71%)
Median time to first emetic episode (min)a 60.5 34.0

Nausea assessments:Number of patients

105 85
Mean nausea score over 24-h postoperative periodb 1.9 2.9

a After administration of study drug.b Nausea measured on a scale of 0-10 with 0 = no nausea, 10 = nausea as bad as it can be.

The populations in Table 12 consisted mainly of women undergoing laparoscopic procedures.

Repeat Dosing in Adults: In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of ondansetron 4 mg postoperatively does not provide additional control of nausea and vomiting.

Ped iatrics

One double-blind, placebo-controlled, US trial was performed in 351 male and female outpatients (aged 2 to 12 years) who received general anesthesia with nitrous oxide and no prophylactic antiemetics. Surgical procedures were unrestricted. Patients who experienced two or more emetic episodes within 2 hours following discontinuation of nitrous oxide were randomized to either single intravenous doses of ondansetron (0.1 mg/kg for pediatric patients weighing 40 kg or less, 4 mg for pediatric patients weighing more than 40 kg) or placebo administered over at least 30 seconds. Ondansetron was significantly more effective than placebo in preventing further episodes of nausea and vomiting. The results of the trial are summarized in Table 13.

T able 13. Therapeutic Response in Prevention of Further Postoperative Nausea and/or Vomiting in Pediatric Patients Aged 2 to 12 Years

Treatment Response Over 24 Hours

Ondansetron n (%)

Placebo n (%)

P- Value

Number of patients

180

171

0 Emetic episodes

96 (53%)

29 (17%)

≤ 0.001

Failurea

84 (47%)

142 (83%)

a Failure was one or more emetic episodes, rescued, or withdrawn.

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