We aimed to evaluate the
antiemetic efficacy, safety, and clinical utility of prophylactic
ondansetron administered at the end of the surgery for the prevention of
postoperative nausea and vomiting (
PONV) in a homogenous population of 54 women undergoing
modified radical mastectomy (MRM). A standard
general anesthetic and perioperative
analgesic technique were used. After surgery, patients received either saline placebo or
ondansetron 4 mg IV. Episodes of
PONV, as well as rescue
antiemetic requirements, were recorded for the first 24 h after surgery. The 24-h incidence of
PONV (33.3% vs 81.5%; P = 0.0010) was significantly lower in the
ondansetron group. The severity of
PONV, evaluated by the number of
emetic episodes per patient (1.59+/-1.90 vs 0.29+/-0.66; P = 0.0029), and the rescue
antiemetic requirement (59.2% vs 14.8%; P = 0.0019) was significantly lower, in the
ondansetron group. Patient satisfaction scores and number needed to prevent
PONV (2.07) were significantly better and therapeutically more favorable in the
ondansetron group. The incidence of adverse events such as
headache,
dizziness, and increased liver
enzyme levels (number needed to harm = infinity) was similar in both groups. Administered at the end of the surgery in adult female patients undergoing
general anesthesia for MRM,
ondansetron 4 mg is effective and safe in preventing
PONV. We recommend the clinical practice of routine prophylactic
ondansetron to prevent
PONV after MRM, as it significantly improves perioperative patient satisfaction and outcome.
IMPLICATIONS: We evaluated the
antiemetic efficacy, safety, and routine use of prophylactic
ondansetron, a "gold standard"
antiemetic, in women undergoing radical breast surgery who were at a high risk of
postoperative vomiting. We analyzed more meaningful "true" and "therapeutic" outcome measures, and we conclude that prophylactic
ondansetron is safe and effective and that its routine use is justified.