Trial Outcomes & Findings for Magnesium Sulfate for Analgesia in Pediatric Transplant (NCT NCT04812028)
NCT ID: NCT04812028
Last Updated: 2024-10-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
approximately 7 days
Results posted on
2024-10-28
Participant Flow
Participant milestones
| Measure |
Liver Transplant - MgSO4
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
9
|
21
|
34
|
|
Overall Study
COMPLETED
|
2
|
9
|
21
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnesium Sulfate for Analgesia in Pediatric Transplant
Baseline characteristics by cohort
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: approximately 7 daysTotal 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).
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Total Opioid Requirement
|
3.31 OME/kg/d
Standard Deviation 1.69
|
5.27 OME/kg/d
Standard Deviation 2.94
|
10.2 OME/kg/d
Standard Deviation 8.32
|
4.1 OME/kg/d
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5Daily opioid requirement will be reported in units of morphine equivalent per body weight.
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Daily Post-operative Opioid Requirement
|
4.3 OME/kg/d
Standard Deviation 1.28
|
5.33 OME/kg/d
Standard Deviation 3.03
|
14.06 OME/kg/d
Standard Deviation 11.6
|
4.97 OME/kg/d
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: approximately 7 daysOral 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).
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
OR Opioid Consumption
|
2.19 OME/kg/d
Standard Deviation 0.3
|
3.6 OME/kg/d
Standard Deviation 2.51
|
4.69 OME/kg/d
Standard Deviation 1.94
|
3.24 OME/kg/d
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: approximately 7 daysOutcome 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
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Delirium/AMS
|
0 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: approximately 7 daysOutcome 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
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Constipation -- Ileus
|
0 Participants
|
5 Participants
|
5 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: approximately 7 daysOutcome 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
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Constipation -- Enema Use
|
0 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: approximately 7 daysPostoperative day where first stooled
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Constipation -- 1st Stool
|
2 day
Interval 1.0 to 3.0
|
4 day
Interval 1.0 to 6.0
|
3.83 day
Interval 0.0 to 7.0
|
3.76 day
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: approximately 7 daysPostoperative day where started enteral feeds
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Bowel Dysmotility -- Feed Initiation
|
2 day
Interval 1.0 to 3.0
|
2.22 day
Interval 1.0 to 4.0
|
2.71 day
Interval 1.0 to 6.0
|
2.06 day
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: approximately 7 daysPostoperative number of emeses as indicator of nausea
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Nausea -- Emeses
|
0 events
Interval 0.0 to 0.0
|
2.44 events
Interval 0.0 to 9.0
|
1.38 events
Interval 0.0 to 5.0
|
1.26 events
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: approximately 7 daysNumber of ondansetron doses
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Nausea -- Antiemetic Use
|
1 antiemetic administrations
Standard Deviation 1.41
|
11.4 antiemetic administrations
Standard Deviation 11.95
|
2.86 antiemetic administrations
Standard Deviation 4.65
|
10.79 antiemetic administrations
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: approximately 7 daysFrequency needing any antiemetic use, measure reported in percentage
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Nausea -- Antiemetic Use
|
50 percentage
|
89 percentage
|
43 percentage
|
94 percentage
|
SECONDARY outcome
Timeframe: approximately 7 daysFrequency of pruritus as measured by Naloxone gtt use, reported as percentage
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Pruritus
|
0 percentage
|
78 percentage
|
14 percentage
|
59 percentage
|
SECONDARY outcome
Timeframe: approximately 7 daysFrequency of urinary retention as measured by straight catheterization requirement, measured in percentage
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
Opioid Side Effect - Urinary Retention
|
0 percentage
|
22 percentage
|
10 percentage
|
18 percentage
|
SECONDARY outcome
Timeframe: up to 32 daysConsecutive days in PICU following operation
Outcome measures
| Measure |
Liver Transplant - MgSO4
n=2 Participants
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 Participants
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control Review Group
n=21 Participants
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 Participants
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
PICU Length of Stay
|
4.19 days
Standard Deviation 0.42
|
7.38 days
Standard Deviation 2.92
|
8.47 days
Standard Deviation 6.97
|
7.29 days
Standard Deviation 7.67
|
Adverse Events
Liver Transplant - MgSO4 Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TPIAT - MgSO4
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Liver Transplant - Control
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
TPIAT - Control
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liver Transplant - MgSO4 Group
n=2 participants at risk
Liver transplant recipients receiving study intervention (magnesium sulfate infusion)
|
TPIAT - MgSO4
n=9 participants at risk
Total Pancreatecomy with Islet Cell Autotransplantation (TPIAT) recipients receiving study intervention (MgSO4 infusion)
|
Liver Transplant - Control
n=21 participants at risk
Retrospective cohort of liver transplant recipients whom did not receive study intervention
|
TPIAT - Control
n=34 participants at risk
Retrospective cohort of TPIAT recipients whom did not receive study intervention
|
|---|---|---|---|---|
|
General disorders
Hypotension
|
100.0%
2/2 • 7 days
|
77.8%
7/9 • 7 days
|
81.0%
17/21 • 7 days
|
79.4%
27/34 • 7 days
|
|
General disorders
Bradycardia
|
0.00%
0/2 • 7 days
|
33.3%
3/9 • 7 days
|
61.9%
13/21 • 7 days
|
23.5%
8/34 • 7 days
|
|
General disorders
Aryrthmia
|
50.0%
1/2 • Number of events 1 • 7 days
|
11.1%
1/9 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
5.9%
2/34 • 7 days
|
|
General disorders
Delirium/Hallucination
|
0.00%
0/2 • 7 days
|
55.6%
5/9 • Number of events 5 • 7 days
|
19.0%
4/21 • Number of events 4 • 7 days
|
20.6%
7/34 • Number of events 7 • 7 days
|
|
General disorders
Pulmonary Edema/Efusion
|
50.0%
1/2 • Number of events 1 • 7 days
|
22.2%
2/9 • Number of events 2 • 7 days
|
33.3%
7/21 • Number of events 7 • 7 days
|
5.9%
2/34 • Number of events 2 • 7 days
|
|
General disorders
Infecrion
|
0.00%
0/2 • 7 days
|
44.4%
4/9 • Number of events 4 • 7 days
|
19.0%
4/21 • Number of events 4 • 7 days
|
44.1%
15/34 • Number of events 15 • 7 days
|
|
General disorders
Prolonged Hypoxia
|
0.00%
0/2 • 7 days
|
11.1%
1/9 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
2.9%
1/34 • Number of events 1 • 7 days
|
|
General disorders
Anaphlaxis
|
0.00%
0/2 • 7 days
|
0.00%
0/9 • 7 days
|
0.00%
0/21 • 7 days
|
2.9%
1/34 • Number of events 1 • 7 days
|
|
General disorders
abnormal movement or sensation
|
50.0%
1/2 • Number of events 1 • 7 days
|
0.00%
0/9 • 7 days
|
0.00%
0/21 • 7 days
|
5.9%
2/34 • Number of events 2 • 7 days
|
|
General disorders
AKI
|
50.0%
1/2 • Number of events 1 • 7 days
|
0.00%
0/9 • 7 days
|
33.3%
7/21 • Number of events 7 • 7 days
|
2.9%
1/34 • Number of events 1 • 7 days
|
|
General disorders
Flushing
|
0.00%
0/2 • 7 days
|
0.00%
0/9 • 7 days
|
19.0%
4/21 • Number of events 4 • 7 days
|
0.00%
0/34 • 7 days
|
|
General disorders
Rash
|
0.00%
0/2 • 7 days
|
0.00%
0/9 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
2.9%
1/34 • Number of events 1 • 7 days
|
|
General disorders
Dizziness
|
0.00%
0/2 • 7 days
|
0.00%
0/9 • 7 days
|
0.00%
0/21 • 7 days
|
5.9%
2/34 • Number of events 2 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place