Early Magnesium Sulfate for Childhood Asthma

Overseen By Jaclyn Urquiola Sorzano, DO

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Disqualifiers: Chronic pulmonary disease, Cerebral palsy, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Magnesium Sulfate for treating childhood asthma?

Research suggests that Magnesium Sulfate can help children with asthma who do not respond well to initial treatments, as it may improve lung function and reduce the need for hospital admission. ^{1 2 3 4 5}

Is magnesium sulfate safe for children with asthma?

Research suggests that magnesium sulfate is generally safe for children with asthma when used in medical settings, such as hospitals, to help with severe asthma attacks. It is often given as an intravenous (IV) infusion or nebulized (inhaled as a mist) and is considered a second-tier treatment when other medications are not enough. ^{3 4 5 6 7}

How is the drug magnesium sulfate unique in treating childhood asthma?

Magnesium sulfate is unique because it is used as a second-tier treatment for children with severe asthma who do not respond well to initial therapies, like beta(2)-agonists. It can be administered early in high doses or as a prolonged infusion to improve lung function and reduce hospital admissions. ^{1 2 3 4 5}

Research Team

Ryan McKee, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for children aged 5-17 who come to the emergency department with a moderate level of breathing difficulty due to asthma. Their parents or caregivers must speak English. It's not suitable for those outside this age range or with different levels of respiratory distress.

Inclusion Criteria

I am between 5 and 17 years old.

I have moderate breathing difficulties.

Exclusion Criteria

Patients who are pregnant

I have a chronic condition like heart disease or myasthenia gravis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either early administration of IV magnesium sulfate or standard care based on randomization

1 week

In-person visits during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Magnesium Sulfate

Trial Overview The study is testing if giving magnesium sulfate within the first hour of arriving at the hospital helps kids with moderate asthma attacks by reducing their stay in the ER, avoiding admission, and lessening the need for intensive care or breathing support.

Participant Groups

Group I: Magnesium Sulfate in the first hour Experimental Treatment 1 Intervention

These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids).

Group II: No Magnesium Sulfate Placebo Group 1 Intervention

These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary.

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

In a study of 54 children with moderate to severe asthma exacerbations, the administration of high-dose magnesium sulfate did not significantly improve asthma symptoms compared to a placebo, as measured by Pulmonary Index scores.

There was no notable difference in hospitalization rates or time to meet discharge criteria between the magnesium and placebo groups, indicating that magnesium sulfate may not be an effective routine treatment for acute asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. Scarfone, RJ., Loiselle, JM., Joffe, MD., et al.[2006]

In a study involving 508 children with severe acute asthma, nebulised magnesium sulphate (MgSO4) showed a statistically significant reduction in asthma severity scores compared to placebo, but the difference was not clinically significant overall.

The most notable benefits of MgSO4 treatment were observed in children with more severe asthma exacerbations and those whose symptoms had lasted less than 6 hours, indicating potential targeted efficacy in specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Powell, C., Kolamunnage-Dona, R., Lowe, J., et al.[2014]

In a study involving 90 children aged 6-14 with acute asthma, the addition of nebulized magnesium sulfate (MgSO4) to salbutamol did not lead to significant improvements in lung function, as measured by peak expiratory flow rate (PEFR).

While both treatment groups showed a decrease in heart rate and improvements in oxygen saturation (SpO2), these changes were not statistically significant, indicating that MgSO4 may not provide additional benefits in managing acute asthma in this pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized Salbutamol with or without Magnesium Sulphate in the Management of Acute Asthma in Children in India: A Randomized Controlled Trial. Siddiqui, H., Siddiqui, SA., Yadav, RK., et al.[2022]

A review of 8 studies involving 447 children found that prolonged magnesium sulfate infusions (over 1 hour) are used for treating refractory asthma, but most studies did not assess clinical outcomes like lung function or hospital admissions.

While magnesium sulfate infusions were generally safe, with only 1.1% of patients experiencing high magnesium levels, adverse events such as hypotension and nausea were more common in those receiving infusions lasting over 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Magnesium Sulfate Infusions for Status Asthmaticus in Children: A Systematic Review. Johnson, PN., Drury, AS., Gupta, N.[2022]

In a study involving 508 children aged 2-15 with acute severe asthma, nebulised magnesium sulphate (MgSO4) showed a statistically significant improvement in asthma severity scores compared to placebo, particularly in children with more severe exacerbations and shorter symptom duration.

The addition of nebulised MgSO4 to standard asthma treatment (salbutamol and ipratropium bromide) was found to be safe, with no significant adverse effects, and may be cost-effective for the NHS, suggesting it could be a beneficial adjunct therapy in managing acute asthma episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Powell, CV., Kolamunnage-Dona, R., Lowe, J., et al.[2022]

A review of 16 studies indicates that intravenous bolus magnesium sulphate is safe for treating children with acute severe asthma in non-critical care settings.

Safety measures, such as line of sight nursing and cardiorespiratory monitoring, are essential when administering magnesium sulphate to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? de Havilland, A., Hariharan, G., Puvvadi, R.[2022]

Magnesium sulfate can be beneficial for asthmatic patients who do not respond well to initial treatments like beta-agonists and corticosteroids, potentially acting as a calcium antagonist and aiding in ion flux across cell membranes.

While routine use of magnesium sulfate in emergency departments for acute asthma is not recommended, it may provide some benefits as an adjunct therapy for severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the intravenous and nebulized magnesium sulfate for the treatment of the acute asthma in the emergence]. Barbosa, FT., Barbosa, LT., Cunha, RM., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Nebulized Salbutamol with or without Magnesium Sulphate in the Management of Acute Asthma in Children in India: A Randomized Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Magnesium Sulfate Infusions for Status Asthmaticus in Children: A Systematic Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

[Use of the intravenous and nebulized magnesium sulfate for the treatment of the acute asthma in the emergence]. [2014]