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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812028
• Other study ID #: PEDS-2019-27677
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 7 days
Secondary	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
Secondary	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.	approximately 7 days
Secondary	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.	approximately 7 days