Undertaken in California, this six-month prospective, observational, non-randomized trial examines the use of ondansetron for the treatment of nausea and vomiting in the prehospital environment.
Paramedics were given 90 minutes training in the use of ondansetron.
A standardized protocol was implemented allowing IV, IM or oral administration of this medication to patients four years of age or older who were experiencing severe nausea or intractable vomiting.
Primary outcome measures included: change in severity of nausea measured by using a 10-point visual analogue scale before and after administration of ondansetron; any adverse effect experienced by patients after receiving the medication.
Of the 2072 patients in the trial, 1320 received IV ondansetron, 674 took an oral dissolving tablet, 77 had an IM injection, and one patient did not receive the drug due to failure of the IV equipment.
Results indicate that the IV route achieved the largest improvement in nausea scores (mean 4.4; 95%C1 4.2, 4.5), followed by IM (mean 3.6; 95% C1 3.0, 4.3), and followed by oral administration (3.3; 95% C1 3.1, 3.5).
Eight patients (0.4%) were reported to have experienced possible minor adverse reactions but the lack of a control group limits the ability to examine whether this is directly attributable to the medication or not.
From this study the authors suggest that ondansetron is a safe and effective drug for use in the prehospital environment.