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临床试验/NCT04812028
NCT04812028已完成2 期

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Total Opioid Requirement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Prospective Experimental Group

Experimental

Participants in this group will prospectively receive the intervention.

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

Total Opioid Requirement

时间窗: 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).

次要结局

  • Daily Post-operative Opioid Requirement(Day 1, Day 2, Day 3, Day 4, Day 5)
  • OR Opioid Consumption(approximately 7 days)
  • Opioid Side Effect - Delirium/AMS(approximately 7 days)
  • Opioid Side Effect - Constipation -- Ileus(approximately 7 days)
  • Opioid Side Effect - Constipation -- Enema Use(approximately 7 days)
  • Opioid Side Effect - Constipation -- 1st Stool(approximately 7 days)
  • Opioid Side Effect - Bowel Dysmotility -- Feed Initiation(approximately 7 days)
  • Opioid Side Effect - Nausea -- Emeses(approximately 7 days)
  • Opioid Side Effect - Nausea -- Antiemetic Use(approximately 7 days)
  • Opioid Side Effect - Pruritus(approximately 7 days)
  • Opioid Side Effect - Urinary Retention(approximately 7 days)
  • PICU Length of Stay(up to 32 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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