A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine
Overview
- Phase
- Phase 4
- Intervention
- Ondansetron
- Conditions
- Pruritus
- Sponsor
- University of Michigan
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Severity of Pruritus
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Elizabeth Putnam
Assistant Professor
University of Michigan
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
Arms & Interventions
Ondansetron IV
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Intervention: Ondansetron
Placebo
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Intervention: Placebo Comparator
Outcomes
Primary Outcomes
Severity of Pruritus
Time Frame: 24 hours
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Incidence of Pruritus
Time Frame: 24 hours
number of participants with any incidence of pruritus
Secondary Outcomes
- Severity of Post Operative Nausea or Vomiting(24 hours)
- Incidence of Post Operative Nausea or Vomiting(24 hours)