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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Experimental Group | Experimental | Participants in this group will prospectively receive the intervention. |
|
| Retrospective Review Group | No Intervention | Participants in this group will have their medical records retrospectively reviewed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| OR Opioid Consumption | Oral Morphine Equivalent use during Operating Room Procedure 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). |
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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:
Control Group:
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| Name | Affiliation | Role |
|---|---|---|
| Gwenyth Fischer, MD | University of Minenesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Transplant - MgSO4 | Liver transplant recipients receiving study intervention (magnesium sulfate infusion) |
| FG001 | TPIAT - MgSO4 | Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion) |
| FG002 | Liver Transplant - Control Review Group | Retrospective cohort of liver transplant recipients whom did not receive study intervention |
| FG003 | TPIAT - Control | Retrospective cohort of TPIAT recipients whom did not receive study intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Transplant - MgSO4 | Liver transplant recipients receiving study intervention (magnesium sulfate infusion) |
| BG001 | TPIAT - MgSO4 | Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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). | Posted | Mean | Standard Deviation | OME/kg/d | approximately 7 days |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liver Transplant - MgSO4 Group | Liver transplant recipients receiving study intervention (magnesium sulfate infusion) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gwenyth Fischer | University of Minnesota | 612-625-9950 | fisch662@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2022 | Aug 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2023 | Aug 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| approximately 7 days |
| Opioid Side Effect - Delirium/AMS | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Delirium or Altered Mental Status | approximately 7 days |
| Opioid Side Effect - Constipation -- Ileus | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of Ileus as indicated in Progress Note | approximately 7 days |
| Opioid Side Effect - Constipation -- Enema Use | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of enema use for constipation | approximately 7 days |
| Opioid Side Effect - Constipation -- 1st Stool | Postoperative day where first stooled | approximately 7 days |
| Opioid Side Effect - Bowel Dysmotility -- Feed Initiation | Postoperative day where started enteral feeds | approximately 7 days |
| Opioid Side Effect - Nausea -- Emeses | Postoperative number of emeses as indicator of nausea | approximately 7 days |
| Opioid Side Effect - Nausea -- Antiemetic Use | Number of ondansetron doses | approximately 7 days |
| Opioid Side Effect - Nausea -- Antiemetic Use | Frequency needing any antiemetic use, measure reported in percentage | approximately 7 days |
| Opioid Side Effect - Pruritus | Frequency of pruritus as measured by Naloxone gtt use, reported as percentage | approximately 7 days |
| Opioid Side Effect - Urinary Retention | Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage | approximately 7 days |
| PICU Length of Stay | Consecutive days in PICU following operation | up to 32 days |
| BG002 | Liver Transplant - Control Review Group | Retrospective cohort of liver transplant recipients whom did not receive study intervention |
| BG003 | TPIAT - Control | Retrospective cohort of TPIAT recipients whom did not receive study intervention |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
| OG002 | Liver Transplant - Control Review Group | Retrospective cohort of liver transplant recipients whom did not receive study intervention |
| OG003 | TPIAT - Control | Retrospective cohort of TPIAT recipients whom did not receive study intervention |
|
|
| Secondary | Daily Post-operative Opioid Requirement | Daily opioid requirement will be reported in units of morphine equivalent per body weight. | Posted | Mean | Standard Deviation | OME/kg/d | Day 1, Day 2, Day 3, Day 4, Day 5 |
|
|
|
| Secondary | OR Opioid Consumption | Oral Morphine Equivalent use during Operating Room Procedure 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). | Posted | Mean | Standard Deviation | OME/kg/d | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Delirium/AMS | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Delirium or Altered Mental Status | Posted | Count of Participants | Participants | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Constipation -- Ileus | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of Ileus as indicated in Progress Note | Posted | Count of Participants | Participants | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Constipation -- Enema Use | Outcome reported as the count of participants who experience opioid side effects during the entire operative and post-operative pediatric intensive care unit (PICU) period. Prevalence of enema use for constipation | Posted | Count of Participants | Participants | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Constipation -- 1st Stool | Postoperative day where first stooled | Posted | Mean | Full Range | day | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Bowel Dysmotility -- Feed Initiation | Postoperative day where started enteral feeds | Posted | Mean | Full Range | day | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Nausea -- Emeses | Postoperative number of emeses as indicator of nausea | Posted | Mean | Full Range | events | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Nausea -- Antiemetic Use | Number of ondansetron doses | Posted | Mean | Standard Deviation | antiemetic administrations | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Nausea -- Antiemetic Use | Frequency needing any antiemetic use, measure reported in percentage | Posted | Number | percentage | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Pruritus | Frequency of pruritus as measured by Naloxone gtt use, reported as percentage | Posted | Number | percentage | approximately 7 days |
|
|
|
| Secondary | Opioid Side Effect - Urinary Retention | Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage | Posted | Number | percentage | approximately 7 days |
|
|
|
| Secondary | PICU Length of Stay | Consecutive days in PICU following operation | Posted | Mean | Standard Deviation | days | up to 32 days |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | TPIAT - MgSO4 | Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion) | 0 | 9 | 0 | 9 | 7 | 9 |
| EG002 | Liver Transplant - Control | Retrospective cohort of liver transplant recipients whom did not receive study intervention | 0 | 21 | 0 | 21 | 17 | 21 |
| EG003 | TPIAT - Control | Retrospective cohort of TPIAT recipients whom did not receive study intervention | 0 | 34 | 0 | 34 | 27 | 34 |
| Bradycardia | General disorders | Non-systematic Assessment |
|
| Aryrthmia | General disorders | Non-systematic Assessment |
|
| Delirium/Hallucination | General disorders | Non-systematic Assessment |
|
| Pulmonary Edema/Efusion | General disorders | Non-systematic Assessment |
|
| Infecrion | General disorders | Non-systematic Assessment |
|
| Prolonged Hypoxia | General disorders | Non-systematic Assessment |
|
| Anaphlaxis | General disorders | Non-systematic Assessment |
|
| abnormal movement or sensation | General disorders | Non-systematic Assessment |
|
| AKI | General disorders | Non-systematic Assessment |
|
| Flushing | General disorders | Non-systematic Assessment |
|
| Rash | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |