Magnesium Sulfate for Analgesia in Pediatric Transplant

Phase 2

Completed

Conditions: Postoperative Pain

Interventions: Drug: Magnesium sulfate

Registration Number: NCT04812028

Lead Sponsor: University of Minnesota

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Experimental Group	Magnesium sulfate	Participants in this group will prospectively receive the intervention.

Primary Outcome Measures

Name	Time	Method
Total Opioid Requirement	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. 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).

Secondary Outcome Measures

Name	Time	Method
Daily Post-operative Opioid Requirement	Day 1, Day 2, Day 3, Day 4, Day 5	Daily opioid requirement will be reported in units of morphine equivalent per body weight.
OR Opioid Consumption	approximately 7 days	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).
Opioid Side Effect - Delirium/AMS	approximately 7 days	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
Opioid Side Effect - Constipation -- Ileus	approximately 7 days	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
Opioid Side Effect - Constipation -- Enema Use	approximately 7 days	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
Opioid Side Effect - Constipation -- 1st Stool	approximately 7 days	Postoperative day where first stooled
Opioid Side Effect - Bowel Dysmotility -- Feed Initiation	approximately 7 days	Postoperative day where started enteral feeds
Opioid Side Effect - Nausea -- Emeses	approximately 7 days	Postoperative number of emeses as indicator of nausea
Opioid Side Effect - Nausea -- Antiemetic Use	approximately 7 days	Frequency needing any antiemetic use, measure reported in percentage
Opioid Side Effect - Pruritus	approximately 7 days	Frequency of pruritus as measured by Naloxone gtt use, reported as percentage
Opioid Side Effect - Urinary Retention	approximately 7 days	Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage
PICU Length of Stay	up to 32 days	Consecutive days in PICU following operation