Pediatric BurnsPhase 1NCT07126795
Magnesium Sulfate in Pediatric Burn Dressing Changes
A Phase 1 study testing magnesium sulfate and Normal Saline (0.9% NaCl) in people with Pediatric Burns, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia/sedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and/or sedative requirements. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Burns
- What is being tested?
- magnesium sulfate and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2027to Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- < 18 years old at time of randomization completion
- admission to HCMC Burn Unit
- Projected multi-day sedated dressing change requirement
- Intention for IV Ketamine as primary analgosedative agent
Who cannot join
- age < 3 years (may lower pending FDA discussions)
- Evidence of hypermagnesemia - pre-study serum Mg2+ level > 2.5 mg/dL
- Evidence of renal dysfunction - serum Cr level > 1.5x hospital upper limit normal for age
- Presence of neuromuscular disease (specifically myasthenia gravis), underlying bradyarrhythmia or heart block
- Bronchospastic disease (asthma, reactive airway disease) which requires continuous magnesium sulfate infusion
- Active prescription of a calcium channel blocker (amlodipine, isradipine, nicardipine, nifedipine, clevidipine, diltiazem, verapamil), cardiac glycoside (digoxin), parenteral nutrition or an infusion for hemodynamic support (epinephrine, norepinephrine, dopamine, dobutamine, milrinone, etc)
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- Known allergy or reaction to magnesium sulfate, aluminum, or a component of the formulation
- Presence of invasive mechanical ventilation
- Anticipation of skin grafting within 5 days of study eligibility
- Anyone whom child protective services are consulted
- Any investigational drug use within 30 days prior to enrollment
- Pregnant or lactating females
- Anyone whom in the opinion of the investigator is at higher than anticipated risk of harm or inability to adhere to protocol
- Patients who choose to opt out of research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Joseph Resch, M.D., 612-481-5885, joseph.resch@hcmed.org
About this study
Official title: Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study
Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia/sedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and/or sedative requirements.
Read the detailed description
Pediatric patients (n=10) suffering severe burn, admitted to the burn unit at Hennepin County Medical Center (Minneapolis, MN) meeting specific inclusion/exclusion criteria will be randomized daily to either intravenous magnesium sulfate (50 mg/kg, max 2 g) or placebo (normal saline) for up to 5 sedated burn dressing changes. Primary aims will be to evaluate safety/feasibility to guide a future larger randomized controlled trial.
- Conditions
- Pediatric Burns
- Being tested
- magnesium sulfate, Normal Saline (0.9% NaCl)
- Keywords
- magnesium sulfate, pediatrics, burn, analgesia, sedation, burn dressing change
- Medical subject headings
- Burns, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
Normal Saline (0.9% NaCl)Drug
Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate Arm | Experimental | Pediatric Burn Patients receiving Ketamine as primary agent for sedated dressing changes, randomized (max 5 randomizations) to either study intervention (Magnesium sulfate) or placebo (Normal saline) Receives: Drug: magnesium sulfate |
| Normal Saline Placebo Arm | Placebo comparator | Placebo Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Adverse Events
Frequency of severe adverse events
Measured: Through Study Completion, Approximately 1 year
Protocol Deviations
Number of Protocol Deviations
Measured: Through Study Completion, Approximately 1 year
Consent Rate
Consent Rate (%)
Measured: Through Study Completion, Approximately 1 year
Enrollment Effort
Enrollment Effort of Study Personnel (hours)
Measured: Through Study Completion, Approximately 1 year
Study Duration Indicator
Duration to Reach Enrollment Target (months)
Measured: Through Study Completion, Approximately 1 year
Effectiveness of Drug Delivery & Timing
Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Measured: Through Study Completion, Approximately 1 year
Extra Blood Draws
Number of Extra Blood Draws per Patient
Measured: Through Study Completion, Approximately 1 year
Secondary outcomes (2)
Ketamine dosage
Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)
Measured: Through Study Completion, Approximately 1 year
Adverse Events
Specific tracking of adverse events related to Magnesium sulfate and deep sedative agents. General tracking of adverse events. Description of severity and relation to magnesium sulfate.
Measured: Through Study Completion, Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startDec 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric BurnsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Resch, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126795
- Sponsor's protocol ID
- HCMC Pediatric Burn Study
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study
- ClinicalTrials.gov ID
- NCT07126795
- Acronym / sponsor ID
- HCMC Pediatric Burn Study
- Conditions
- Pediatric Burns
- Keywords
- magnesium sulfate, pediatrics, burn, analgesia, sedation, burn dressing change
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Dec 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia/sedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and/or sedative requirements.
Detailed description
Pediatric patients (n=10) suffering severe burn, admitted to the burn unit at Hennepin County Medical Center (Minneapolis, MN) meeting specific inclusion/exclusion criteria will be randomized daily to either intravenous magnesium sulfate (50 mg/kg, max 2 g) or placebo (normal saline) for up to 5 sedated burn dressing changes. Primary aims will be to evaluate safety/feasibility to guide a future larger randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate Arm | Experimental | Drug: magnesium sulfatePediatric Burn Patients receiving Ketamine as primary agent for sedated dressing changes, randomized (max 5 randomizations) to either study intervention (Magnesium sulfate) or placebo (Normal saline) |
| Normal Saline Placebo Arm | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Placebo |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- < 18 years old at time of randomization completion
- admission to HCMC Burn Unit
- Projected multi-day sedated dressing change requirement
- Intention for IV Ketamine as primary analgosedative agent
Key exclusion criteria (14 listed)
- age < 3 years (may lower pending FDA discussions)
- Evidence of hypermagnesemia - pre-study serum Mg2+ level > 2.5 mg/dL
- Evidence of renal dysfunction - serum Cr level > 1.5x hospital upper limit normal for age
- Presence of neuromuscular disease (specifically myasthenia gravis), underlying bradyarrhythmia or heart block
- Bronchospastic disease (asthma, reactive airway disease) which requires continuous magnesium sulfate infusion
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 sulfateIV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change | Drug | Magnesium Sulfate Arm |
| Normal Saline (0.9% NaCl)Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change | Drug | Normal Saline Placebo Arm |
Primary outcome
Severe Adverse Events
Time frame: Through Study Completion, Approximately 1 year
Frequency of severe adverse events
Protocol Deviations
Time frame: Through Study Completion, Approximately 1 year
Number of Protocol Deviations
Consent Rate
Time frame: Through Study Completion, Approximately 1 year
Consent Rate (%)
Enrollment Effort
Time frame: Through Study Completion, Approximately 1 year
Enrollment Effort of Study Personnel (hours)
Study Duration Indicator
Time frame: Through Study Completion, Approximately 1 year
Duration to Reach Enrollment Target (months)
Effectiveness of Drug Delivery & Timing
Time frame: Through Study Completion, Approximately 1 year
Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Extra Blood Draws
Time frame: Through Study Completion, Approximately 1 year
Number of Extra Blood Draws per Patient
2 secondary outcomes
Ketamine dosage
Time frame: Through Study Completion, Approximately 1 year
Adverse Events
Time frame: Through Study Completion, Approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing magnesium sulfate and Normal Saline (0.9% NaCl) in people with Pediatric Burns, run by Hennepin Healthcare Research Institute 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 14 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Adverse Events (time frame: Through Study Completion, Approximately 1 year). The study lists 7 primary outcomes in all. 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 9 Oct 2026.