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Hypertonic saline and Salbutamol in children who get admitted with mild to moderate exacerbation of asthma

Nebulised Salbutamol and hypertonic saline versus nebulised salbutamol and normal saline in the treatment of children with acute exacerbation of asthma: A Randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058421
Enrollment
58
Registered
2023-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J452- Mild intermittent asthma

Interventions

Intervention1: NEBULIZED SALBUTAMOL WITH HYPERTONIC SALINE: The child will be nebulized with salbutamol (5mg/ml ) @ 0.15 mg/kg ( maximum - 5mg ) plus hypertonic saline - 3ml at 0 , 20 and 40 minutes

Sponsors

SHIVARAMAN P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with clinically diagnosed Asthma aged 6 years - 18 years presenting to pediatric OPD , Pediatric chest clinic with mild/moderate exacerbation as assessed by PRAM score

Exclusion criteria

Exclusion criteria: Pre-existing chest wall/ neuromuscular disease/ other pulmonary conditions such as CF, ILD, Bronchiectasis, PCD, etc. Children who received a short acting beta-2 agonist within 6 hrs Children who received a long-acting beta-2 agonist within 12 hrs Children not able to perform Spirometry. Children involved in any other trial. Repeated admissions

Design outcomes

Primary

MeasureTime frame
FEV1 measured before and at 60 minutes after nebulization.Timepoint: 0,20,40 and 60 minutes

Secondary

MeasureTime frame
Clinical severity score (PRAM) measured at baseline and at 60 minutes after nebulization.Timepoint: 0,20,40 and 60 minutes;Other Spirometry parameters (PEFR; MMER) measured at baseline and at 60 minutes.Timepoint: 0,20,40 and 60 minutes

Countries

India

Contacts

Public ContactRakesh Lodha

AIIMS NEW DELHI

rakesh_lodha@hotmail.com01126593621

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026