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

Phase 4

Terminated

• Conditions: Pruritus; Nausea/Vomiting
• Interventions: Drug: Placebo Comparator; Drug: Ondansetron

• Registration Number: NCT03262038
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2017-12-07
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2020-08
• Disposition First Submitted: 2020-08-14
• Disposition First Submitted QC: 2020-08-14
• Disposition First Posted: 2020-08-21
• Results First Submitted: 2020-12-22
• Results First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Results First Posted: 2021-01-19
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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)
Ondansetron IV	Ondansetron	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)

Primary Outcome Measures

Name	Time	Method
Severity of Pruritus	24 hours	number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Incidence of Pruritus	24 hours	number of participants with any incidence of pruritus

Secondary Outcome Measures

Name	Time	Method
Severity of Post Operative Nausea or Vomiting	24 hours	number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)
Incidence of Post Operative Nausea or Vomiting	24 hours	number of participants with any incidence of postoperative nausea or vomiting

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States