Phase 2
N=66
Magnesium Sulfate for Analgesia in Pediatric Transplant
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04812028 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Total Opioid Requirement — 3.31; 5.27; 10.2; 4.1 OME/kg/d
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Magnesium sulfate (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Requirement |
3.31; 5.27; 10.2; 4.1 | — |
| SECONDARY Daily Post-operative Opioid Requirement |
4.3; 5.33; 14.06; 4.97 | — |
| SECONDARY OR Opioid Consumption |
2.19; 3.6; 4.69; 3.24 | — |
| SECONDARY Opioid Side Effect - Delirium/AMS |
0; 5; 5; 7 | — |
| SECONDARY Opioid Side Effect - Constipation -- Ileus |
0; 5; 5; 21 | — |
| SECONDARY Opioid Side Effect - Constipation -- Enema Use |
0; 2; 5; 11 | — |
| SECONDARY Opioid Side Effect - Constipation -- 1st Stool |
2; 4; 3.83; 3.76 | — |
| SECONDARY Opioid Side Effect - Bowel Dysmotility -- Feed Initiation |
2; 2.22; 2.71; 2.06 | — |
| SECONDARY Opioid Side Effect - Nausea -- Emeses |
0; 2.44; 1.38; 1.26 | — |
| SECONDARY Opioid Side Effect - Nausea -- Antiemetic Use |
50; 89; 43; 94 | — |
| SECONDARY Opioid Side Effect - Nausea -- Antiemetic Use |
50; 89; 43; 94 | — |
| SECONDARY Opioid Side Effect - Pruritus |
0; 78; 14; 59 | — |
| SECONDARY Opioid Side Effect - Urinary Retention |
0; 22; 10; 18 | — |
| SECONDARY PICU Length of Stay |
4.19; 7.38; 8.47; 7.29 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04812028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.