- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812028
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
August 11, 2023 updated by: University of Minnesota
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prospective Experimental Group
Participants in this group will prospectively receive the intervention.
|
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.
|
No Intervention: Retrospective Review Group
Participants in this group will have their medical records retrospectively reviewed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Opioid Requirement
Time Frame: 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.
|
approximately 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Post-operative Opioid Requirement
Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5
|
Daily opioid requirement will be reported in units of morphine equivalent per body weight.
|
Day 1, Day 2, Day 3, Day 4, Day 5
|
Requested (PRN) Opioid Use
Time Frame: approximately 7 days
|
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
|
Opioid Side Effects
Time Frame: approximately 7 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gwenyth Fischer, MD, University of Minenesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
August 10, 2023
Study Completion (Actual)
August 10, 2023
Study Registration Dates
First Submitted
March 19, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- PEDS-2019-27677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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