Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201156
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-12-15
Brief Title:
Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Sponsor:
Khyber Teaching Hospital
Organization:
Khyber Teaching Hospital
Study Overview
Official Title:
Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 015 mgkg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 Lmin
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 childs 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
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 015 mgkg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 Lmin
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 childs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None