Magnesium Sulfate for Analgesia in Pediatric Transplant

NCT04812028 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PEDS-2019-27677
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  approximately 7 days

Secondary Outcomes (13)

• Daily Post-operative Opioid Requirement

  Day 1, Day 2, Day 3, Day 4, Day 5

• OR Opioid Consumption

  approximately 7 days

• Opioid Side Effect - Delirium/AMS

  approximately 7 days

• Opioid Side Effect - Constipation -- Ileus

  approximately 7 days

• Opioid Side Effect - Constipation -- Enema Use

  approximately 7 days

Study Arms (2)

Prospective Experimental Group

EXPERIMENTAL

Participants in this group will prospectively receive the intervention.

Drug: Magnesium sulfate

Retrospective Review Group

NO INTERVENTION

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

Interventions

Magnesium sulfate 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.

Prospective Experimental Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Gwenyth Fischer
• Organization: University of Minnesota

fisch662@umn.edu

612-625-9950

Study Officials

• Gwenyth Fischer, MD

  University of Minenesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)