Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

K

Khyber Teaching Hospital

Status

Enrolling

Conditions

Childhood Asthma With Acute Exacerbation

Treatments

Device: Metered Dose Inhaler With Spacer Device

Study type

Interventional

Funder types

Other

Identifiers

NCT06201156
847/DME/KMC

Details and patient eligibility

About

The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min. For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.

Enrollment

160 estimated patients

Sex

All

Ages

6 to 24 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 6 to 24 months

  • Patients of both gender
  • Patients presenting to emergency department with bilateral wheeze

Exclusion criteria

Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).

  • Patients with history of congenital heart disease.
  • Patients with history of intubation for longer than 1 week during the neonatal period.
  • Patients having symptoms consistent with croup.
  • Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

Group A / Nebulizer Group
Active Comparator group
Description:
Group A/ Nebulizer group will receive 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.
Treatment:
Device: Metered Dose Inhaler With Spacer Device
Group B / MDI with Spacer Device Group
Experimental group
Description:
Group B/ MDI with Spacer Group will receive 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals.
Treatment:
Device: Metered Dose Inhaler With Spacer Device

Trial contacts and locations

1

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Central trial contact

Arooj Khan, MBBS

Data sourced from clinicaltrials.gov

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