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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
Sponsor:
Information provided by (Responsible Party):
Elizabeth Putnam, 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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Ondansetron Drug: Placebo Comparator Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: Ondansetron
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.




Primary Outcome Measures :
  1. Incidence of Pruritus [ Time Frame: 24 hours ]
    number of participants with any incidence of pruritus

  2. Severity of Pruritus [ Time Frame: 24 hours ]
    number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)


Secondary Outcome Measures :
  1. Incidence of post operative nausea vomiting [ Time Frame: 24 hours ]
    number of participants with any incidence of postoperative nausea vomiting

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Elizabeth Putnam, MD University of Michigan

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Responsible Party: Elizabeth Putnam, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03262038     History of Changes
Other Study ID Numbers: HUM00124202
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Putnam, University of Michigan:
intrathecal morphine
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Morphine
Ondansetron
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents