At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis
In Brief
A clinical study evaluating Methotrexate, Ondansetron, and 1 other intervention for Juvenile Idiopathic Arthritis. Completed, enrolled 52 participants across 11 sites.
Detailed Summary
Far too many kids and families live in dread over the weekly nausea and vomiting caused by methotrexate - a medicine that controls joint swelling in Juvenile Arthritis patients. If methotrexate is not tolerated, expensive alternative biological medications may be started. This registry-based pragmatic randomized controlled trial will evaluate if routine premedication with the anti-emetic drug Ondansetron, reduces nausea and vomiting and increases the proportion of children able to continue methotrexate. By preventing nausea before it starts, the investigators hope to give kids and families a better quality of life and see a more cost-effective use of medication.
Study Details
Timeline
Interventions
Children in both the intervention and control group will receive Methotrexate dosed as prescribed by the attending rheumatologist
Children in the intervention group will be prescribed premedication with oral ondansetron. Children in the control group will be prescribed ondansetron ONLY if the child reports nausea/vomiting during regular treatment care with Methotrexate
Children in both intervention and control group will receive folic acid or folinic acid dosed as prescribed by the attending rheumatologist.