Randomized, Double-Blind, Crossover, Placebo-Controlled Trial of Intravenous Ondansetron for the Prevention of Intrathecal Chemotherapy-Induced Vomiting in Children

Abstract

Vomiting induced by intrathecal chemotherapy can be greatly reduced by the intravenous administration of ondansetron before the procedure, and severe vomiting can be virtually eliminated.

Ondansetron attenuates co-morbid depression and anxiety associated with obesity by inhibiting the biochemical alterations and improving serotonergic neurotransmission

“…Eisensamer et al (2003) documented the functional antagonist property of the SSRI class of antidepressants on 5-HT 3 receptors. Ondansetron, a 5-HT 3 receptor antagonist is currently being used for the treatment of post-operative nausea and vomiting (PONV) and chemotherapy induced nausea and vomiting (CINV) (Tramer et al, 1997;Parker et al, 2001;Cohen, 2007). Several preclinical studies have demonstrated the antidepressant and anxiolytic effects of serotonergic type 3 (5-HT 3 ) receptor antagonists, such as ondansetron (Ramamoorthy et al, 2008;Rajkumar and Mahesh, 2010;Roychoudhury and Kulkarni, 1997), 3-methoxy-N-p-tolylquinoxalin-2-carboxamide (QCM-4) (Kurhe et al, 2014a) and (4-phenylpiperazin-1-yl) (quinoxalin-2-yl) methanone (4a) (Kurhe et al, 2015).…”

Pediatric oncology sedation trial (POST): A double‐blind randomized study

“…Further confusing this area of clinical concern is the report of the apparent benefit of ondansetron, in a non‐randomized study of children receiving intra‐thecal chemotherapy 12. An additional contribution to the context of the POST study is an authoritative editorial 13, which states “Finally, from a societal cost‐benefit perspective, the current data do not support the use of 5HT3 antagonists for routine anti‐emetic prophylaxis.” However, Parker et al 14 have reported the efficacy of ondansetron for the prevention of intra‐thecal chemotherapy‐induced vomiting in 26 children with acute leukemia who were sedated usually (sic) with a combination of midazolam and ketamine; in a randomized, double‐blind, cross‐over, placebo‐controlled trial.…”

Safety of ondansetron loading doses in children with cancer

“…Four adverse events (headache in two episodes, dizziness, and warm feeling) were considered to be at least probably related to the standard dose (5 mg/m 2 ) compared to one AE (headache) probably related to the medium dose of 10 mg/m 2 . In a randomized, double-blind, placebo-controlled trial, Parker et al [15] had applied 48 OLD of 0.45 mg/kg, corresponding to about 14 mg/m 2 . No analysis of adverse events was performed.…”

“…Of these, 140 (84%) AE were mild, 21 (13%) moderate, and 5 (3.0%) severe. The most common AE were hypotension and fatigue (31 each), injection site reaction (16), headache (15), hot flashes/flushes (14), and dizziness (11; Table 2). …”