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

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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

Tracking Information
First Submitted Date  ICMJE March 19, 2021
First Posted Date  ICMJE March 23, 2021
Last Update Posted Date June 8, 2022
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2021)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2021)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Official Title  ICMJE Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Prospective Experimental Group
    Participants in this group will prospectively receive the intervention.
    Intervention: Drug: Magnesium sulfate
  • No Intervention: Retrospective Review Group
    Participants in this group will have their medical records retrospectively reviewed.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2021)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joseph Resch, MD 702-575-4648 resch066@umn.edu
Contact: Lexie Goertzen lexieg@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04812028
Other Study ID Numbers  ICMJE PEDS-2019-27677
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gwenyth Fischer, MD University of Minenesota
PRS Account University of Minnesota
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP