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

NCT03262038 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HUM00124202
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus; Nausea/Vomiting

Keywords

intrathecal morphine

Outcome Measures

Primary Outcomes (2)

• Incidence of Pruritus

  number of participants with any incidence of pruritus

  24 hours

• Severity of Pruritus

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

  24 hours

Secondary Outcomes (2)

• Incidence of Post Operative Nausea or Vomiting

  24 hours

• Severity of Post Operative Nausea or Vomiting

  24 hours

Study Arms (2)

Ondansetron IV

EXPERIMENTAL

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)

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo Comparator

Interventions

Ondansetron DRUG

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.

Ondansetron IV

Placebo Comparator DRUG

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

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pruritus; Nausea; Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Elizabeth Putnam
• Organization: University of Michigan

eread@umich.edu

734-763-2435

Study Officials

• Elizabeth Putnam, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug (ondansetron/placebo) will be masked for all but the pharmacist
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: December 7, 2017
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)