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

Phase 4TerminatedNCT03262038

University of Michigan46 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pruritus Nausea/Vomiting

Interventions

OndansetronDRUG

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.

Placebo ComparatorDRUG

This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Incidence of Pruritus

number of participants with any incidence of pruritus

Time frame: 24 hours

Severity of Pruritus

number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)

Time frame: 24 hours

Secondary Outcomes

Incidence of Post Operative Nausea or Vomiting

number of participants with any incidence of postoperative nausea or vomiting

Time frame: 24 hours

Severity of Post Operative Nausea or Vomiting

number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)

Time frame: 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.