Magnesium Sulfate for Analgesia in Pediatric Transplant

NCT ID: NCT04812028

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-08-10

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prospective Experimental Group

Participants in this group will prospectively receive the intervention.

Group Type: EXPERIMENTAL

Magnesium sulfate

Intervention Type: DRUG

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.

Retrospective Review Group

Participants in this group will have their medical records retrospectively reviewed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwenyth Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minenesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PEDS-2019-27677

Identifier Type: -

Identifier Source: org_study_id