University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT04812028
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.
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Notify Me3 year–18 year
All sexes
Interventional
Phase 2
Minneapolis, Minnesota, 55455, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Experimental Group:
Control Group:
Exclusion criteria
Experimental Group:
Control Group:
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.
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.
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).
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.
Time frame: approximately 7 days
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).
Time frame: approximately 7 days
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
Time frame: approximately 7 days
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
Time frame: approximately 7 days
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
Time frame: approximately 7 days
Postoperative day where first stooled
Time frame: approximately 7 days
Postoperative day where started enteral feeds
Time frame: approximately 7 days
Postoperative number of emeses as indicator of nausea
Time frame: approximately 7 days
Number of ondansetron doses
Time frame: approximately 7 days
Frequency needing any antiemetic use, measure reported in percentage
Time frame: approximately 7 days
Frequency of pruritus as measured by Naloxone gtt use, reported as percentage
Time frame: approximately 7 days
Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage
Time frame: up to 32 days
Consecutive days in PICU following operation
University of Minnesota
Other
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
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