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

Primary Purpose

Pruritus, Nausea/Vomiting

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Placebo Comparator
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pruritus focused on measuring intrathecal morphine

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron IV

Placebo

Arm Description

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: 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)

Outcomes

Primary Outcome Measures

Incidence of Pruritus
number of participants with any incidence of pruritus
Severity of Pruritus
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)

Secondary Outcome Measures

Incidence of Post Operative Nausea or Vomiting
number of participants with any incidence of postoperative nausea or vomiting
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)

Full Information

First Posted
August 23, 2017
Last Updated
December 22, 2020
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03262038
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed no difference between groups
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Nausea/Vomiting
Keywords
intrathecal morphine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study drug (ondansetron/placebo) will be masked for all but the pharmacist
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron IV
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
Primary Outcome Measure Information:
Title
Incidence of Pruritus
Description
number of participants with any incidence of pruritus
Time Frame
24 hours
Title
Severity of Pruritus
Description
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of Post Operative Nausea or Vomiting
Description
number of participants with any incidence of postoperative nausea or vomiting
Time Frame
24 hours
Title
Severity of Post Operative Nausea or Vomiting
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Putnam, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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