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Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?

Pruritus Clinical Trial

Official title:
A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine

Clinical Trial Summary

This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.

Clinical Trial Description

Pruritus is one of the most common and bothersome side effects of intrathecal morphine (ITM) in children, with a reported incidence of 30-60%. Clinicians, who have witnessed unbearable itching and scratching in their young patients after intrathecal morphine, may be reluctant to offer this effective pain control to future patients, for fear of these unpleasant sequelae. A study previously found a 40% incidence of pruritus in young children who received intrathecal morphine for major urologic surgery. This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. control group, where pruritus and PONV are treated with PRN only medications. Enrollment of 3-17 year olds who are undergoing urologic or orthopedic operative procedures who are scheduled to receive low dose (4-5 mcg/kg) intrathecal morphine for pain management. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03262038
Study type Interventional
Source University of Michigan
Contact
Status Terminated
Phase Phase 4
Start date December 7, 2017
Completion date August 20, 2019
View Details
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