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Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

Primary Purpose

Status Asthmaticus

Status

Completed

Phase

Phase 1

Locations

Pakistan

Study Type

Interventional

Intervention

Magnesium Sulfate 500 mg/ml+ ventolin

Ventolin

About this trial

This is an interventional treatment trial for Status Asthmaticus focused on measuring asthma, nebulized, magnesium sulphate

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children between 2 to 12 years of age.
Children with the diagnosis of asthma having a pram score of more than 4.
Children with reactive airways

Exclusion Criteria:

Critically ill children who require intubation or mechanical ventilation.
Having hypersensitivity or allergy to MgSO4.
with history of chronic lung impairment.
Whose parents are not giving informed consent for participation in research.

Sites / Locations

Rabia Asif

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nebulized Ventolin

Nebulized Magnesium Sulphate + Ventolin

Arm Description

Nebulized Ventolin will given to 1st group after every 20 min for 1 hour

Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.

Outcomes

Primary Outcome Measures

Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline

The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+).

Change from baseline Suprasternal indrawing

Absent (0) , Present (2)

Change from baseline Scalene retractions

Absent (0) , Present (2)

Change from baseline Wheezing

Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry

Change from baseline Air entry

Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)

Change from baseline Oxygen saturation on room air

>93% (0), 90%-93% (1) or <90% (2)

Secondary Outcome Measures

Hospital stay

curtailment in the length of hospital stay

Hospital stay

curtailment in the length of hospital stay

Full Information

NCT ID

NCT04929626

First Posted

May 10, 2021

Last Updated

April 3, 2023

Sponsor

Ziauddin University

1. Study Identification

Unique Protocol Identification Number

NCT04929626

Brief Title

Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

Official Title

Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

November 12, 2022 (Actual)

Study Completion Date

November 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.

Detailed Description

This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Status Asthmaticus

Keywords

asthma, nebulized, magnesium sulphate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes

Masking

ParticipantCare Provider

Masking Description

The principal investigator was aware of the intervention being provided. Others were masked including the participant and care provider.

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebulized Ventolin

Arm Type

Active Comparator

Arm Description

Nebulized Ventolin will given to 1st group after every 20 min for 1 hour

Arm Title

Nebulized Magnesium Sulphate + Ventolin

Arm Type

Experimental

Arm Description

Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate 500 mg/ml+ ventolin

Other Intervention Name(s)

MgSO4

Intervention Description

3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form

Intervention Type

Drug

Intervention Name(s)

Ventolin

Other Intervention Name(s)

Salbutamol

Intervention Description

it will be given to control group in nebulized form after every 20 min in 1st hour

Primary Outcome Measure Information:

Title

Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline

Description

Time Frame