Status:
TERMINATED
Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
Lead Sponsor:
University of Michigan
Conditions:
Pruritus
Nausea/Vomiting
Eligibility:
All Genders
3-17 years
Phase:
PHASE4
Brief 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 b...
Detailed 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 scr...
Eligibility Criteria
Inclusion
- 3-17 years
- weight \</= 100kg
- scheduled for urologic or orthopedic procedure necessitating intrathecal morphine
- ability to use verbal or pictorial pain assessment tools and techniques
- informed consent and (if applicable) assent
Exclusion
- Inability to use verbal or pictorial pain scoring scales
- hypersensitivity to selective 5-HT receptor antagonists
- diagnosed congenital long QT syndrome
- severe hepatic impairment
- pregnancy or nursing mothers
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03262038
Start Date
December 7 2017
End Date
August 20 2019
Last Update
January 19 2021
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109