83357
document
Randomized double-blind , placebo-controlled evaluation of oral ondansetron in the prevention of nausea and vomiting associated with fractionated total-body irradiation . PURPOSE To evaluate oral ondansetron in the prevention of total-body irradiation ( TBI ) -induced nausea and vomiting . METHODS Twenty patients who received 4 days of TBI as part of their preparative regimen before bone marrow transplantation were randomized to receive either 8-mg oral doses of ondansetron or placebo . Administration of drug was double-blinded . Initial rescue therapy consisted of intravenous ( i.v . ) ondansetron 0.15 mg/kg following two or more emetic episodes between successive fractions of TBI or five total emetic episodes during the 4 days of therapy . If , after receipt of i.v . ondansetron , patients had two or more emetic episodes between fractions of TBI or five total emetic episodes , additional antiemetics were administered . RESULTS Patients who received oral ondansetron had significantly fewer emetic episodes compared with those who received placebo ( P = .005 ) over the entire 4-day study period . Oral ondansetron was also significantly superior to placebo with respect to the time of onset of emesis or rescue ( P = .003 ) . Six of 10 patients treated with oral ondansetron completed the study without additional antiemetic therapy , while none of 10 patients who received placebo completed the study without rescue antiemetic therapy . Six placebo patients who received initial rescue therapy with i.v . ondansetron required no additional antiemetics . No relationships were apparent between peak ondansetron concentration ( Cmax ) or area under the concentration versus time curve ( AUC ) and number of emetic episodes . CONCLUSION Oral ondansetron is an effective therapy for the prevention of emesis induced by TBI .
83358
Intervention_Control
placebo-controlled
83359
Intervention_Pharmacological
oral ondansetron
83360
Intervention_Pharmacological
oral ondansetron
83361
Intervention_Pharmacological
oral doses of ondansetron
83362
Intervention_Control
placebo
83363
Intervention_Pharmacological
ondansetron
83364
Intervention_Pharmacological
ondansetron
83365
Intervention_Pharmacological
ondansetron
83366
Intervention_Control
placebo
83367
Intervention_Pharmacological
ondansetron
83368
Intervention_Control
placebo
83369
Intervention_Pharmacological
ondansetron
83370
Intervention_Pharmacological
antiemetic therapy
83371
Intervention_Control
placebo
83372
Intervention_Pharmacological
antiemetic therapy
83373
Intervention_Control
placebo
83374
Intervention_Pharmacological
initial rescue therapy
83375
Intervention_Pharmacological
ondansetron
83376
Intervention_Pharmacological
Oral ondansetron
83377
Outcome_Physical
emetic episodes
83378
Outcome_Physical
time of onset of emesis or rescue
83379
Outcome_Other
rescue antiemetic therapy .
83380
Outcome_Other
additional antiemetics .
83381
Outcome_Other
peak ondansetron concentration ( Cmax ) or area under the concentration versus time curve ( AUC ) and number of emetic episodes .
83382
Participant_Condition
nausea
83383
Participant_Condition
vomiting
83384
Participant_Condition
fractionated total-body irradiation
83385
Participant_Condition
total-body irradiation ( TBI ) -induced nausea and vomiting
83386
Participant_Sample-size
Twenty