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

NCT03262038 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-01-19

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Putnam, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2019-08-20
Completion
2019-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262038 on ClinicalTrials.gov