A randomized, double-blind comparison of the antiemetic effect of metoclopramide and lorazepam with or without dexamethasone in patients receiving high-dose cisplatin.

Thirty-seven patients with advanced incurable malignancies who were receiving their first course of cisplatin (greater than or equal to 90 mg/m2 bolus), alone or in combination with other antineoplastic agents, were entered in this randomized, double-blind study to determine the antiemetic efficacy of the addition of high-dose dexamethasone to lorazepam plus metoclopramide. All patients received lorazepam (1.5 mg/m2) and metoclopramide (2.0 mg/kg) intravenously (IV) 30 minutes before cisplatin, with the same dose of metoclopramide repeated 1.5, 3.5, 6.5, and 9.5 hours after the 30-minute cisplatin infusion. Patients were randomized to receive dexamethasone (0.5 mg/kg) or placebo by slow bolus injection 30 minutes before cisplatin. All patients were hospitalized for 24 hours and evaluated by observation after cisplatin and a patient questionnaire before discharge. Eighteen patients received metoclopramide and lorazepam without dexamethasone: six (33%) reported no vomiting and four (22%) reported no nausea or vomiting. Nineteen patients also received dexamethasone: 14 (74%) had no vomiting and 13 (68%) reported no nausea or vomiting. These differences were statistically significantly different (P = 0.013 and 0.005, respectively). The side effects attributable to the antiemetic regimen were somnolence (100%), confusion (8%), and diarrhea (46%), and were the same in both arms. Dexamethasone significantly improved the antiemetic efficacy of metoclopramide plus lorazepam without adding toxicity. This three-drug combination gave a high rate of control of acute emesis induced by high-dose cisplatin.

RCT Entities:   Population Interventions Outcomes