--- title: Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients? nct_id: NCT03262038 overall_status: TERMINATED phase: PHASE4 sponsor: University of Michigan study_type: INTERVENTIONAL primary_condition: Pruritus countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03262038.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03262038" ct_last_update_post_date: 2021-01-19 last_seen_at: "2026-05-12T06:43:48.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients? **Official Title:** A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine **NCT ID:** [NCT03262038](https://clinicaltrials.gov/study/NCT03262038) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Interim analysis showed no difference between groups - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 46 - **Lead Sponsor:** University of Michigan - **Conditions:** Pruritus, Nausea/Vomiting - **Start Date:** 2017-12-07 - **Completion Date:** 2019-08-20 - **CT.gov Last Update:** 2021-01-19 ## 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. ## Eligibility - **Minimum age:** 3 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 3-17 years * weight \