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Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04812028
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
To use magnesium sulfate as adjuvant analgesia by implementing a treatment protocol in order to determine whether can benefit pediatric pain in post-operative transplanted patients and decrease overall opioid consumption.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Magnesium sulfate Phase 2

Detailed Description:
The post-operative ICU course for children receiving liver transplants and TPIAT (total pancreatectomy with islet cell autotransplantation) includes a number of different challenges, one of which includes pain. Pain is treated with both medications and approaches without medications (such as music and other distraction techniques). Opioids are one such effective pain medication which is universally used, however like all medications has risks of certain side effects (such as nausea, constipation, itching, and others). Modern research has searched for other medications and methods to treat pain in both children and adults. In this study, the investigators aim to apply one of these methods that has been shown to be effective in certain operative populations through a medicine called Magnesium-Sulfate, which may be a safe way to decrease the use of other pain medications (specifically opioids). Magnesium is already a physiologic electrolyte the body uses, which are consumed from certain foods. Used as an IV medication to reach higher levels of magnesium can work to decrease pain via its action on specific nerve receptors. Magnesium-Sulfate will be given at the beginning of transplant surgery for consented liver and TPIAT transplant patients, and continue an infusion for 48 hours into their ICU course. The investigators will monitor side effects and treat pain the same way otherwise the care team would without magnesium to determine whether there is any beneficial effect that can be applied to children in the future.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prospective Experimental Group
Participants in this group will prospectively receive the intervention.
 Drug: Magnesium sulfate
Magnesium sulfate (MgSO4) will be administered intravenously at induction of anesthesia as a 30-minute bolus dose of 50 mg/kg (maximum 2 grams) in the OR, followed by a 15 mg/kg/hr IV infusion for 48 hours or once the patient has transferred out of the PICU, whichever comes first.
No Intervention: Retrospective Review Group
Participants in this group will have their medical records retrospectively reviewed.


Outcome Measures
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Primary Outcome Measures :
  1. Total Opioid Requirement [ Time Frame: approximately 7 days ]
    Total opioid requirement during the entire operative and post-operative pediatric intensive care unit (PICU) period will be reported in units of morphine equivalent per body weight.


Secondary Outcome Measures :
  1. Daily Post-operative Opioid Requirement [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5 ]
    Daily opioid requirement will be reported in units of morphine equivalent per body weight.

  2. Requested (PRN) Opioid Use [ Time Frame: approximately 7 days ]
    Requested (as opposed to scheduled) opioid use during the entire operative and post-operative pediatric intensive care unit (PICU) period will be reported in units of morphine equivalent per body weight.

  3. Opioid Side Effects [ Time Frame: approximately 7 days ]
    Outcome reported as the percent of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Experimental Group:

- Be scheduled for and receive a liver transplant or total pancreatectomy and islet cell autotransplantation

Control Group:

- Received a liver transplant or total pancreatectomy and islet cell autotransplantation.

Exclusion Criteria:

Experimental Group:

  • Pregnant or unwilling to abstain from sex if not practicing birth control during participation in the study.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Known allergic reactions to components of the MgSO4
  • History of heart block or myasthenia graves in past medical history.
  • Presence of cardiac pacemaker
  • Any patient with preoperative creatinine level > 1.5x upper limit of normal.

Control Group:

  • Any patient who had filed as research-exempt (opt-out of research previously).
  • Any patient with preoperative creatinine level > 1.5x upper limit of normal.
Contacts and Locations
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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): NCT04812028


Contacts
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Contact: Joseph Resch, MD 702-575-4648 resch066@umn.edu
Contact: Lexie Goertzen lexieg@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Lexie Goertzen    612-625-5904    lexieg@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Gwenyth Fischer, MD University of Minenesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04812028    
Other Study ID Numbers: PEDS-2019-27677
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents