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

University of Michigan

Status and phase: Terminated; Phase 4

Conditions: Nausea/Vomiting; Pruritus

Treatments: Drug: Placebo Comparator; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT03262038

HUM00124202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Ondansetron IV

Experimental group

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)

Treatment:

Drug: Ondansetron

Placebo

Placebo Comparator group

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)

Treatment:

Drug: Placebo Comparator