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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03262038
Other study ID # HUM00124202
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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