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

Overview

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.

Full Title of Study: “A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 20, 2019

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.

Interventions

  • Drug: Ondansetron
    • This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
  • Drug: Placebo Comparator
    • This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.

Arms, Groups and Cohorts

  • Experimental: 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)
  • Placebo Comparator: 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)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Pruritus
    • Time Frame: 24 hours
    • number of participants with any incidence of pruritus
  • Severity of Pruritus
    • Time Frame: 24 hours
    • number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)

Secondary Measures

  • Incidence of Post Operative Nausea or Vomiting
    • Time Frame: 24 hours
    • number of participants with any incidence of postoperative nausea or vomiting
  • Severity of Post Operative Nausea or Vomiting
    • Time Frame: 24 hours
    • number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizabeth Putnam, Assistant Professor – University of Michigan
  • Overall Official(s)
    • Elizabeth Putnam, MD, Principal Investigator, University of Michigan

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