Clinical trial NCT04812028: Magnesium Sulfate for Analgesia in Pediatric Transplant
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Opioid Requirement
timeFrame: approximately 7 days
Secondary outcomes:
measure: Daily Post-operative Opioid Requirement
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 5
measure: OR Opioid Consumption
timeFrame: approximately 7 days
measure: Opioid Side Effect - Delirium/AMS
timeFrame: approximately 7 days
measure: Opioid Side Effect - Constipation -- Ileus
timeFrame: approximately 7 days
measure: Opioid Side Effect - Constipation -- Enema Use
timeFrame: approximately 7 days
measure: Opioid Side Effect - Constipation -- 1st Stool
timeFrame: approximately 7 days
measure: Opioid Side Effect - Bowel Dysmotility -- Feed Initiation
timeFrame: approximately 7 days
measure: Opioid Side Effect - Nausea -- Emeses
timeFrame: approximately 7 days
measure: Opioid Side Effect - Nausea -- Antiemetic Use
timeFrame: approximately 7 days
measure: Opioid Side Effect - Nausea -- Antiemetic Use
timeFrame: approximately 7 days
measure: Opioid Side Effect - Pruritus
timeFrame: approximately 7 days
measure: Opioid Side Effect - Urinary Retention
timeFrame: approximately 7 days
measure: PICU Length of Stay
timeFrame: up to 32 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minenesota
name: Gwenyth Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References: