Magnesium Sulfate for Analgesia in Pediatric Transplant

Phase 2CompletedNCT04812028

University of Minnesota66 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postoperative Pain

Interventions

Magnesium sulfateDRUG

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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).

Time frame: approximately 7 days

Secondary Outcomes

Daily Post-operative Opioid Requirement

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

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).

Time frame: 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

Time frame: 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

Time frame: approximately 7 days

Data from ClinicalTrials.gov

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