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Completed

NCT Number: NCT04812028

Magnesium Sulfate for Analgesia in Pediatric Transplant

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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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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).

Secondary outcomes

  1. 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.

  2. OR Opioid Consumption

    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).

  3. Opioid Side Effect - Delirium/AMS

    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

  4. Opioid Side Effect - Constipation -- Ileus

    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

  5. Opioid Side Effect - Constipation -- Enema Use

    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

  6. Opioid Side Effect - Constipation -- 1st Stool

    Time frame: approximately 7 days

    Postoperative day where first stooled

  7. Opioid Side Effect - Bowel Dysmotility -- Feed Initiation

    Time frame: approximately 7 days

    Postoperative day where started enteral feeds

  8. Opioid Side Effect - Nausea -- Emeses

    Time frame: approximately 7 days

    Postoperative number of emeses as indicator of nausea

  9. Opioid Side Effect - Nausea -- Antiemetic Use

    Time frame: approximately 7 days

    Number of ondansetron doses

  10. Opioid Side Effect - Nausea -- Antiemetic Use

    Time frame: approximately 7 days

    Frequency needing any antiemetic use, measure reported in percentage

  11. Opioid Side Effect - Pruritus

    Time frame: approximately 7 days

    Frequency of pruritus as measured by Naloxone gtt use, reported as percentage

  12. Opioid Side Effect - Urinary Retention

    Time frame: approximately 7 days

    Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage

  13. PICU Length of Stay

    Time frame: up to 32 days

    Consecutive days in PICU following operation

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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