Magnesium Sulfate for Childhood Burns

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Hennepin Healthcare Research Institute

Must be taking: Ketamine

Must not be taking: Calcium channel blockers, Cardiac glycosides

Disqualifiers: Renal dysfunction, Neuromuscular disease, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 5

Duration: Approximately 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how magnesium sulfate can reduce the need for strong sedatives during dressing changes for children with burns. The goal is to determine if magnesium sulfate makes these procedures more comfortable by potentially lowering the amount of ketamine or other sedatives required. Children in a burn unit needing multiple sedated dressing changes with ketamine might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially beneficial treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are actively prescribed certain medications like calcium channel blockers or cardiac glycosides. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that magnesium sulfate is likely to be safe for children?

Research has shown that magnesium sulfate is usually safe for children. A study with 43 children demonstrated a very good safety record, with most experiencing no serious side effects. This study also provided valuable insights into how children's bodies process magnesium sulfate, aiding future treatments.

Dr. Meltzer reported positive results using magnesium sulfate for burns, suggesting it might be safe and effective for pain relief in these cases. Although this trial remains in the early stages and further research is necessary to confirm its safety, these findings are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Magnesium sulfate is unique because it offers a potential new approach to managing pain and inflammation in pediatric burn patients. Unlike the standard treatments like opioids or non-steroidal anti-inflammatory drugs (NSAIDs), magnesium sulfate may reduce the need for strong pain medications by acting as a muscle relaxant and modulating nerve function. Researchers are excited about this treatment as it could minimize the side effects associated with traditional pain management, providing a safer option for kids undergoing sedated dressing changes.

What evidence suggests that magnesium sulfate might be an effective treatment for pediatric burn pain management?

In this trial, participants will be randomized to receive either Magnesium Sulfate or a placebo (Normal Saline) during sedated dressing changes for pediatric burn patients. Research has shown that magnesium sulfate might help treat burns in children by reducing the need for other sedatives. One study found that using magnesium on burn wounds helped them heal faster. This suggests that magnesium could also make dressing changes less painful or reduce the need for sedation. While magnesium sulfate is known to shorten hospital stays for children with asthma, its use for burns remains under investigation. Early signs are promising, but more research is needed to confirm its effectiveness for burns. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children under 18 with deep burns who need IV Ketamine for pain during dressing changes. They must be admitted to HCMC Burn Unit and not have asthma, heart issues, muscle disease, high magnesium levels, or renal dysfunction. Kids under 3 or on certain medications are excluded.

Inclusion Criteria

I am under 18 years old.

I plan to use IV Ketamine for pain and sedation.

I will need multiple days of sedation for dressing changes.

Exclusion Criteria

I need continuous magnesium sulfate for my asthma or reactive airway disease.

Presence of invasive mechanical ventilation

Evidence of hypermagnesemia - pre-study serum Mg2+ level > 2.5 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pediatric patients undergo up to 5 sedated burn dressing changes with either magnesium sulfate or placebo

Approximately 1 year

Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

Trial Overview The study tests if adding magnesium sulfate to normal saline helps reduce the amount of ketamine/sedatives needed during burn dressing changes in kids. It's a prospective trial where patients are observed over time to see how well the treatment works.

How Is the Trial Designed?

Group I: Magnesium Sulfate Arm Experimental Treatment 1 Intervention

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)

Group II: Normal Saline Placebo Arm Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

Citations

1. withpower.com withpower.com/trial/phase-1-burns-2026-b0fa8

Magnesium Sulfate for Childhood Burns · Info for Participants Trial Overview The study tests if adding magnesium sulfate to normal saline helps reduce the amount of ketamine/sedatives needed during burn dressing changes in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417923002140

The effect of topical magnesium on healing of pre-clinical ... Applying magnesium (2% and 4%) in burn wounds reduces the treatment period and accelerates wound healing.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726077/

Pediatric Burns: A Systematic Review and Meta-Analysis on ... This review consolidates data on the epidemiology, outcomes, and management of pediatric burns presenting to emergency departments.

4. mdpi.com mdpi.com/2227-9067/12/8/1064

A Systematic Review and Meta-Analysis of Clinical Trials Conclusions: Magnesium sulfate reduces hospitalizations in moderate-to-severe pediatric asthma, although it does not improve other relevant clinical outcomes.

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.860921/full

Efficacy and Safety of Prolonged Magnesium Sulfate ... The purpose of this study was to evaluate the efficacy and safety of prolonged magnesium sulfate infusion as an advanced therapy.

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/440181

Magnesium Sulphate in Burns Dr. Meltzer mentions the good results which he has obtained by the use of magnesium sulphate in burns.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497407/

Magnesium Sulfate in Pediatric Emergency Medicine Preliminary results from 43 enrolled children demonstrate excellent safety profiles and provide valuable pharmacokinetic data to guide future ...

8. mdpi.com mdpi.com/2075-4426/14/8/788

Severity and Clinical Outcomes of Pediatric Burns—A ... The overall mortality rate was 2.5%, with higher rates among patients with TBSA greater than 40%. These results highlight the need for targeted ...