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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnesium sulfate
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective Experimental Group

Retrospective Review Group

Arm Description

Participants in this group will prospectively receive the intervention.

Participants in this group will have their medical records retrospectively reviewed.

Outcomes

Primary Outcome Measures

Total Opioid Requirement
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

Daily Post-operative Opioid Requirement
Daily opioid requirement will be reported in units of morphine equivalent per body weight.
Requested (PRN) Opioid Use
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
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.

Full Information

First Posted
March 19, 2021
Last Updated
August 11, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04812028
Brief Title
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Official Title
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Experimental Group
Arm Type
Experimental
Arm Description
Participants in this group will prospectively receive the intervention.
Arm Title
Retrospective Review Group
Arm Type
No Intervention
Arm Description
Participants in this group will have their medical records retrospectively reviewed.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Opioid Requirement
Description
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.
Time Frame
approximately 7 days
Secondary Outcome Measure Information:
Title
Daily Post-operative Opioid Requirement
Description
Daily opioid requirement will be reported in units of morphine equivalent per body weight.
Time Frame
Day 1, Day 2, Day 3, Day 4, Day 5
Title
Requested (PRN) Opioid Use
Description
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.
Time Frame
approximately 7 days
Title
Opioid Side Effects
Description
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.
Time Frame
approximately 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwenyth Fischer, MD
Organizational Affiliation
University of Minenesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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