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Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics

NCT04465175 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-07-13

No results posted yet for this study

Summary

Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and 12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown that it has beneficial effect in treating acute asthma in children ; it reduces the hospital stay and the rate of admission as well as the ventilation rate .

Aim : To compare single dose Magnesium sulphate that is typically given in the emergency department verses two doses of magnesium sulphate in treating acute moderate-severe asthma exacerbation in paediatric age group Research hypothesis : Children who are treated with two doses MgSO4 are more likely to have improvement in their PRAM score and are less likely to be admitted to the ward, HD or ICU Primary outcome : Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation Secondary outcome : Reduce admission rate to general ward, PICU and HD . Demonstrate the safety profile of double dose of magnesium sulphate.

Study Design : prospective blinded randomized trial

Study population : children age 3-13 years who presented to Royal hospital paediatric emergency with moderate-severe acute asthma

Intervention : two doses magnesium sulphate

Comparison : Placebo

Outcome : Improvement in PRAM score

Conditions

  • Asthma in Children

Interventions

DRUG

Magnesium Sulfate

Second dose magnesium sulphate infusion over one hour

DRUG

Placebo

Normal saline (2.5 ml/kg) infusion over one hour

Sponsors & Collaborators

  • Oman Medical Speciality Board

    lead OTHER_GOV

Principal Investigators

  • Noora Al-Alawi, Resident · Oman Medical Specialty Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465175 on ClinicalTrials.gov