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

Pruritus Clinical Trial

Official title:

A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03262038
• Other study ID #: HUM00124202
• Status: Terminated
• Phase: Phase 4
• Start date: December 7, 2017
• Est. completion date: August 20, 2019

Study information

• Verified date: August 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea/Vomiting
• Pruritus
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pruritus	number of participants with any incidence of pruritus	24 hours
Primary	Severity of Pruritus	number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)	24 hours
Secondary	Incidence of Post Operative Nausea or Vomiting	number of participants with any incidence of postoperative nausea or vomiting	24 hours
Secondary	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)	24 hours