Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
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|ClinicalTrials.gov Identifier: NCT03262038|
Recruitment Status : Terminated (Interim analysis showed no difference between groups)
First Posted : August 25, 2017
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pruritus||Drug: Ondansetron Drug: Placebo Comparator||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Study drug (ondansetron/placebo) will be masked for all but the pharmacist|
|Official Title:||A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine|
|Actual Study Start Date :||December 7, 2017|
|Actual Primary Completion Date :||August 20, 2019|
|Actual Study Completion Date :||August 20, 2019|
Experimental: Ondansetron IV
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)
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: Placebo
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)
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.
- Incidence of Pruritus [ Time Frame: 24 hours ]number of participants with any incidence of pruritus
- Severity of Pruritus [ Time Frame: 24 hours ]number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
- Incidence of post operative nausea vomiting [ Time Frame: 24 hours ]number of participants with any incidence of postoperative nausea vomiting
- Severity of post operative nausea vomiting [ Time Frame: 24 hours ]number of participants who Indicated mild post operative nausea vomiting (no treatment needed) or severe postoperative nausea vomiting (treatment needed)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262038
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Elizabeth Putnam, MD||University of Michigan|