Clinical trial NCT03262038: Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
Official title: A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pruritus
Nausea/Vomiting
Keywords: intrathecal morphine
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine
Primary purpose: PREVENTION

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 by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Incidence of Pruritus
timeFrame: 24 hours
measure: Severity of Pruritus
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of Post Operative Nausea or Vomiting
timeFrame: 24 hours
measure: Severity of Post Operative Nausea or Vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elizabeth Putnam, MD
role: PRINCIPAL_INVESTIGATOR
References: