Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 12/12/2018 |
| Start Date: | December 7, 2017 |
| End Date: | December 1, 2021 |
| Contact: | Elizabeth Putnam, MD |
| Email: | eread@med.umich.edu |
| Phone: | 734 6476923 |
A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine
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.
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.
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.
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.
Inclusion Criteria:
- 3-17 years
- weight
- 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
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