Effectiveness of Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Acute Asthma in Children in Suez Canal University Hospital Emergency Department: A Randomized Control Trial
Phase: PHASE3
Conditions: Bronchial Asthma
Sponsor: Suez Canal University

                                              
 
Effectiveness of Salbutamol Administration by Nebulizer versus Metered Dose 
Inhaler in Acute Asthma in Children in Suez Canal University Hospital Emergency 
Department: A Randomized Control Trial 
March 10th 2018 
 
 

Study Protocol 
 
Study design 
Single-blinded randomized control trial. 
 
Study location 
Pediatric Emergency Department in Suez Canal University Hospital. 
 
Study population 
This study includes patients presenting with an acute exacerbation of asthma at the 
Pediatric Emergency Department in Suez Canal University Hospital. 
 
Inclusion criteria: 
▪ Children ranging from 2 – 14 years old. 
▪ Both genders will be included. 
▪ Patients with an acute exacerbation of asthma who were previously 
diagnosed with asthma. 
Exclusion criteria: 
▪ Patients with arrhythmia and cardiac diseases. 
▪ Patients with thyroid diseases.  
▪ Patients with bronchiolitis or pneumonia. 
▪ Patients with status asthmaticus requiring immediate pediatric 
intensive care unit hospitalization. 
 
 
 
 
 
Sampling 
All children fulfilling the inclusion criteria will be included consecutively until the calculated 
sample size had been reached. 

 
                                                         Sample size 
The sample size was calculated using the following formula:   
   
Where: 
n= sample size 
Zα/2 = 1.96 (The critical value that divides the central 95% of the Z distribution from 
the 5% in the tail) 
Zβ = 0.84 (The critical value that separates the lower 20% of the Z distribution from 
the upper 80%) 
σ = the estimate of the standard deviation = 1.5  
µ1= mean in the nebulizer group = 4.4  
µ2 = mean in the metered-dose inhaler group = 3.3  
Therefore, by calculation, the sample size was equal to 30 cases per group, giving a total 
sample size of 60 cases. 
 
 
 
Methods of data collection 
 
 
Infants and children known to have asthma coming to the Pediatric Emergency 
Department of Suez Canal University Hospital and fulfilling the inclusion criteria will be 
assessed according to the following clinical respiratory score: 

 
(Mild 0-3      moderate 4-7      severe 8-12)  
 
The target population are patients who presented with moderate to severe wheezing 
(score 4-12). 
Randomization will take place through a box that contained 60 thick envelopes, in which 
either nebulizer or spacer are written on 30 each, and each time an envelope is picked 
out by the assistant nurse in the emergency room to avoid any selection bias till our 
sample is fulfilled.  
The assessment of the respiratory score before and after the treatment will be performed 
by an independent pediatrician resident who isn`t involved in the decision-making and 
randomization of treatment. This physician will be asked to assess initially and then 
reassess after the equipment had been removed to avoid any bias. 
 
 

CONSORT Flow Diagram to be filled in during the study: 
 
 
Assessed for eligibility (n=  ) 
Excluded  (n=   ) 
   Not meeting inclusion criteria (n=  ) 
   Declined to participate (n=  ) 
   Other reasons (n=  ) 
Analysed  (n=  ) 
 Excluded from analysis (give reasons) (n=  ) 
Lost to follow-up (give reasons) (n=  ) 
Discontinued intervention (give reasons) (n=  ) 
Allocated to intervention (n=  ) 
 Received allocated intervention (n=  ) 
 Did not receive allocated intervention (give 
reasons) (n=  ) 
Lost to follow-up (give reasons) (n=  ) 
Discontinued intervention (give reasons) (n=  ) 
Allocated to intervention (n=  ) 
 Received allocated intervention (n=  ) 
 Did not receive allocated intervention (give 
reasons) (n=  ) 
Analysed  (n=  ) 
 Excluded from analysis (give reasons) (n=  ) 
Allocation 
Analysis 
Follow-Up 
Randomized (n=  ) 
Enrollment 

 
Dosage and administration: 
The nebulizer group will receive salbutamol aerosol solution (Farcolin® 0.121 gm/20ml 
solution) in a dose of 0.15 mg/kg weight, up to a maximum of 5 mg in 3.5 ml of normal 
saline solution. Aerosol is generated by jet nebulizers (Afnor oxygen flow meter) powered 
by oxygen and delivered via a face mask till the whole solution is vaporized every 20 min 
during the first hour (a maximum of three nebulization /hr). A flow rate of 7 L/min is used. 
(Liu, Covar, and Leung, 2016)    
 
The metered dose inhaler with spacer group will receive two puffs of salbutamol 
(Ventolin® evohaler 100 mcg/puff) every 10 min 5 times over 1 hr with a maximum of 10 
puffs/hr, using a spacer device with a face mask (Smart care chamber 500ml volume). 
Following each puff, the children will take 7 breaths from the spacer device held in place.   
(Rubilar, Castro-Rodriguez and Girardi, 2000) 
 
Assessment: 
 
Patients will be reassessed after each treatment, if improved we can stop treatment and 
follow up after 2 hrs. Score <4 is considered a success while score>4 is failure of therapy. 
If not improved, we continue till the maximum number of treatment mentioned above.   
Patients will be compared together according to the following characteristics: duration of 
treatment (preparation and delivery time), clinical outcome, patient satisfaction after 
treatment and hospitalization rate.  
Each patient will have a form: Page 1 is an informed consent to be signed before 
randomization of treatment. Page 2 includes the following items that will be filled by 
parents after receiving the treatment;  
            1-personal data (name, age, address and telephone number). In addition, the 
researcher’s phone number will be accessible to the patients. 

2- Medical history (other illnesses, medications and degree of asthma either 
intermittent or persistent) 
3-Clinical assessment (clinical respiratory score before and after treatment) 
4-Patient satisfaction with given modality on a Likert scale from 1-5. This will be 
asked by the blinded assessor and included questions regarding: 
• Comfort with modality used 
• Duration of modality used 
• Ease of administration 
• Confidence in repeating treatment on their own at home if required 
  
 

                                 Statistical analysis of the data (Kotz et al, 2006) 
 
Data will be fed to the computer and analyzed using IBM SPSS software package 
version 20.0. (Armonk, NY: IBM Corp) (Kirkpatrick, Feeney, 2013). Qualitative data will 
be described using number and percent. The Kolmogorov-Smirnov test is used to verify 
the normality of distribution. Quantitative data will be described using range (minimum 
and maximum), mean, standard deviation and median. Significance of the obtained 
results will be judged at the 5% level.  
The used tests will be  
1 - Chi-square test  
For categorical variables, to compare between different groups (gender, address, 
satisfaction, admission) 
2 - Fisher’s Exact or Monte Carlo correction 
Correction for chi-square when more than 20% of the cells have expected count less 
than 5 
3 - Student t-test 
 
For normally distributed quantitative variables, to compare between two studied 
groups (delivery and preparation time) 
4 - Mann Whitney test 
For abnormally distributed quantitative variables, to compare between two studied 
groups (age, percentage of improvement of clinical respiratory score and satisfaction). 
  
 
 
 
 
                                              
 
 
 

    Ethical Considerations 
 
▪ An informed consent will be obtained from legal guardian of all patients included 
in this study after full explanation of the aim of the study, benefits and hazards of 
the procedures. 
▪ Standardized protocols are used for evaluation. 
▪ The legal guardians have the right to withdraw without affecting the medical care 
expected to be offered to them. 
▪ Confidentiality of all data and test results of all the study population will be 
preserved. 
▪ The new modality introduced is a well-established form of administration and is not 
expected to cause any side effects that would not happen with the standard mode 
of administration (nebulizer).