Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children.
The main question this study aimed to answer was:
Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone?
Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma.
Participants:
(i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours
(ii) Had their asthma symptoms assessed before and after treatment
(iii) Were discharged with continued treatment and counseling if stable
This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.
Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) & baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Nebulization | Experimental | Combined Salbutamol and Ipratropium Bromide |
|
| Single Nebulization | Active Comparator | Salbutamol Nebulization alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol (Ventolin®) | Drug | Children were given 0.5% salbutamol aerosol solution (0.15 mg/kg weight, up to a maximum of 5 mg) in 5mL of normal saline solution for 7 min every 20 min for 2 h, and then every 30 min for two more hours. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Asthma Score (PAS) | Asthma severity was assessed using Pulmonary Asthma score. It uses respiratory rate, wheezing, inspiration to expiration ratio (I:E) and use of accessory muscles graded 0 - 3 with total score of 12. | On presentation and four hours after treatment. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Muhammad Aslam Sheikh, FCPS | Children's Hospital and Institute of Child Health, Multan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Institute of Child Health | Multan | Punjab Province | 60000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21332430 | Background | Iramain R, Lopez-Herce J, Coronel J, Spitters C, Guggiari J, Bogado N. Inhaled salbutamol plus ipratropium in moderate and severe asthma crises in children. J Asthma. 2011 Apr;48(3):298-303. doi: 10.3109/02770903.2011.555037. Epub 2011 Feb 21. | |
| 26968269 | Background | Memon BN, Parkash A, Ahmed Khan KM, Gowa MA, Bai C. Response to nebulized salbutamol versus combination with ipratropium bromide in children with acute severe asthma. J Pak Med Assoc. 2016 Mar;66(3):243-6. |
Not provided
Not provided
Since the study involves children, there are strict ethical guidelines regarding data privacy and protection of minors' health information. Sharing detailed IPD may risk re-identification.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| salbutamol + ipratropium bromide nebules | Drug | In addition to Salbutamol nebulization, children received ipratropium bromide nebulization. Ipratropium bromide solution (250 mcg in children <20 kg weight or 500 mcg in children >=20 kg) every 20 min for the first 2 hours then every 30 min for 2 hours more will be given in between the salbutamol nebulization. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask. |
|
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided