Magnesium Sulfate for Analgesia in Pediatric Transplant

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Magnesium sulfate

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: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. OME/kg is often the recorded value in studies, however the patients had variable PICU courses (i.e. duration in days different between patients, as well as well as admission times altering POD#0 data, etc), so the opioid consumption was standardized to the duration of their course (i.e. OME/kg/d).	approximately 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Post-operative Opioid Requirement	Daily opioid requirement will be reported in units of morphine equivalent per body weight.	Day 1, Day 2, Day 3, Day 4, Day 5
OR Opioid Consumption	Oral Morphine Equivalent use during Operating Room Procedure OME/kg is often the recorded value in studies, however the patients had variable PICU courses (i.e. duration in days different between patients, as well as well as admission times altering POD#0 data, etc), so the opioid consumption was standardized to the duration of their course (i.e. OME/kg/d).	approximately 7 days
Opioid Side Effect - Delirium/AMS	Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Delirium or Altered Mental Status	approximately 7 days
Opioid Side Effect - Constipation -- Ileus	Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of Ileus as indicated in Progress Note	approximately 7 days
Opioid Side Effect - Constipation -- Enema Use	Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of enema use for constipation	approximately 7 days
Opioid Side Effect - Constipation -- 1st Stool	Postoperative day where first stooled	approximately 7 days
Opioid Side Effect - Bowel Dysmotility -- Feed Initiation	Postoperative day where started enteral feeds	approximately 7 days
Opioid Side Effect - Nausea -- Emeses	Postoperative number of emeses as indicator of nausea	approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use	Number of ondansetron doses	approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use	Frequency needing any antiemetic use, measure reported in percentage	approximately 7 days
Opioid Side Effect - Pruritus	Frequency of pruritus as measured by Naloxone gtt use, reported as percentage	approximately 7 days
Opioid Side Effect - Urinary Retention	Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage	approximately 7 days
PICU Length of Stay	Consecutive days in PICU following operation	up to 32 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Gwenyth Fischer, MD, University of Minenesota

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Reproductive Control Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Anti-Arrhythmia Agents; Membrane Transport Modulators; Anticonvulsants; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: PEDS-2019-27677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No