Postoperative PainPhase 2NCT04812028
Magnesium Sulfate for Analgesia in Pediatric Transplant
A Phase 2 study testing Magnesium sulfate in people with Postoperative Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 10 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain
- Being tested
- Magnesium sulfate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Experimental Group | Experimental | Participants in this group will prospectively receive the intervention. Receives: Drug: Magnesium sulfate |
| Retrospective Review Group | No intervention | Participants in this group will have their medical records retrospectively reviewed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Requirement
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).
Measured: approximately 7 days
Secondary outcomes (13)
Daily Post-operative Opioid Requirement
Daily opioid requirement will be reported in units of morphine equivalent per body weight.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5
OR Opioid Consumption
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).
Measured: approximately 7 days
Opioid Side Effect - Delirium/AMS
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
Measured: approximately 7 days
Opioid Side Effect - Constipation -- Ileus
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
Measured: approximately 7 days
Opioid Side Effect - Constipation -- Enema Use
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
Measured: approximately 7 days
Opioid Side Effect - Constipation -- 1st Stool
Postoperative day where first stooled
Measured: approximately 7 days
Opioid Side Effect - Bowel Dysmotility -- Feed Initiation
Postoperative day where started enteral feeds
Measured: approximately 7 days
Opioid Side Effect - Nausea -- Emeses
Postoperative number of emeses as indicator of nausea
Measured: approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use
Number of ondansetron doses
Measured: approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use
Frequency needing any antiemetic use, measure reported in percentage
Measured: approximately 7 days
Opioid Side Effect - Pruritus
Frequency of pruritus as measured by Naloxone gtt use, reported as percentage
Measured: approximately 7 days
Opioid Side Effect - Urinary Retention
Frequency of urinary retention as measured by straight catheterization requirement, measured in percentage
Measured: approximately 7 days
PICU Length of Stay
Consecutive days in PICU following operation
Measured: up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenyth Fischer, MD, Principal investigator, University of Minenesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812028
- Sponsor's protocol ID
- PEDS-2019-27677
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2021
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
- ClinicalTrials.gov ID
- NCT04812028
- Acronym / sponsor ID
- PEDS-2019-27677
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Experimental Group | Experimental | Drug: Magnesium sulfateParticipants in this group will prospectively receive the intervention. |
| Retrospective Review Group | No intervention | –Participants in this group will have their medical records retrospectively reviewed. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be scheduled for and receive a liver transplant or total pancreatectomy and islet cell autotransplantation
- Received a liver transplant or total pancreatectomy and islet cell autotransplantation.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateMagnesium 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. | Drug | Prospective Experimental Group |
Primary outcome
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).
13 secondary outcomes
Daily Post-operative Opioid Requirement
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
OR Opioid Consumption
Time frame: approximately 7 days
Opioid Side Effect - Delirium/AMS
Time frame: approximately 7 days
Opioid Side Effect - Constipation -- Ileus
Time frame: approximately 7 days
Opioid Side Effect - Constipation -- Enema Use
Time frame: approximately 7 days
Opioid Side Effect - Constipation -- 1st Stool
Time frame: approximately 7 days
Opioid Side Effect - Bowel Dysmotility -- Feed Initiation
Time frame: approximately 7 days
Opioid Side Effect - Nausea -- Emeses
Time frame: approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use
Time frame: approximately 7 days
Opioid Side Effect - Nausea -- Antiemetic Use
Time frame: approximately 7 days
Opioid Side Effect - Pruritus
Time frame: approximately 7 days
Opioid Side Effect - Urinary Retention
Time frame: approximately 7 days
PICU Length of Stay
Time frame: up to 32 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenyth Fischer, MD principal investigator
University of Minenesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium sulfate in people with Postoperative Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Requirement (time frame: approximately 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.