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

Abstract

Background: There is limited evidence to support the use of an anti-emetic with the administration of intra-thecal chemotherapy. Nor is there adequate clarity on analgesic strategies for children with cancer undergoing painful procedures.

Procedures: A double-blind, randomized, placebo-controlled, factorial trial was performed in children with acute lymphoblastic leukemia undergoing combined bone marrow aspirations and lumbar punctures during maintenance therapy. The study was designed to measure the effect of adding ondansetron and fentanyl to a standard combination of midazolam and propofol.

Results: During the first 12 hr following the procedures, patients experienced significantly less vomiting/retching and less disruption of activity while receiving ondansetron, and recorded significantly lower pain scores while receiving fentanyl.

Conclusions: This study provides evidence that the addition of an analgesic (fentanyl) and an anti-emetic (ondansetron) to the combination of a sedative (midazolam) and an anesthetic (propofol) is of measurable benefit in children who undergo procedures that are painful and risk the consequence of nausea and vomiting.