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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 23  |  Issue : 1  |  Page : 81-85

Effectiveness of salbutamol administered through a metered-dose inhaler with nebuliser amongst children for acute asthma treatment


1 Assistant Professor, Department of Pediatric Nursing, TN MGR Medical University, Tamil Nadu, India
2 Professor, Department of Child Health, TN MGR Medical University, Tamil Nadu, India
3 Charge Nurse, Department of Pediatric Nursing, TN MGR Medical University, Tamil Nadu, India
4 Respiratory Therapist, Department of Child Health, TN MGR Medical University, Tamil Nadu, India
5 Professor, Department of Pediatric Nursing, College of Nursing, Christian Medical College, Vellore, TN MGR Medical University, Tamil Nadu, India

Date of Submission17-Oct-2021
Date of Decision02-May-2022
Date of Acceptance11-May-2022
Date of Web Publication05-Jul-2022

Correspondence Address:
Ms. Deena Edwin
College of Nursing, Christian Medical College, Vellore, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijcn.ijcn_98_21

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  Abstract 


Administration of salbutamol by metered-dose inhaler (MDI) with spacer is as effective as nebuliser in terms of clinical response and patient outcome. In addition, fewer side effects and lesser hospital admission rates are recorded with this method. Changing the practice of using nebuliser to MDI with spacer as the preferred mode of treatment for mild-to-moderate asthma has been studied. In this study, 68 children between the age groups of 5 and 18 years with mild-to-moderate severity of asthma admitted in the paediatric emergency service and the child health outpatient department were studied to compare the effect of salbutamol delivered via MDI with salbutamol through nebuliser for acute asthma treatment. In this study, 70 children with asthma were randomly allocated to the MDI and nebuliser groups. The standardised Modified Pulmonary Index Score was assessed by the clinical assessor before and 10 min after the intervention. The findings revealed that the clinical outcome was highly significant in both the groups. However, the feasibility of using MDI with spacer in comparison to nebuliser was found to be highly significant in relation to the effectiveness, utilisation of hospital resources (treatment preparation, delivery time and cost) and acceptability to patients. Results of the study carried out in the paediatric population indicate that MDI with spacer is as effective as nebuliser in the treatment of children with mild and moderate acute asthma exacerbations in the hospital setting. However, MDI with spacer has more additional benefits such as fewer side effects, less time consumed to administer the treatment, cost-effective, portable and easier to use than nebulisers.

Keywords: Effectiveness, metered-dose inhaler, Modified Pulmonary Index Score, nebuliser, salbutamol


How to cite this article:
Edwin D, Varkki SD, Violet B, Reddy HP, Ravindran V, Nayak R. Effectiveness of salbutamol administered through a metered-dose inhaler with nebuliser amongst children for acute asthma treatment. Indian J Cont Nsg Edn 2022;23:81-5

How to cite this URL:
Edwin D, Varkki SD, Violet B, Reddy HP, Ravindran V, Nayak R. Effectiveness of salbutamol administered through a metered-dose inhaler with nebuliser amongst children for acute asthma treatment. Indian J Cont Nsg Edn [serial online] 2022 [cited 2022 Dec 7];23:81-5. Available from: https://www.ijcne.org/text.asp?2022/23/1/81/349827




  Introduction Top


Asthma is the most common chronic illness in children, with a prevalence estimated at 5%–10% in developing countries, and is a major reason for paediatric emergency department visits (6%–7% of all annual emergency visits in our hospital). It is also a significant reason for hospital admission worldwide.[1] Asthma is just a public health problem for developed countries. However, in developing countries, the incidence of the disease varies greatly. India has an estimated 15–20 million asthmatics. In India, rough estimates indicate a prevalence between 10% and 15% in 5–11-year-old children. School survey in Vellore showed a prevalence of 5.9% of asthma in children. Bronchial asthma affects a large number of children in India, and the findings indicate that the prevalence of asthma in children in India is increasing rapidly than previously understood.

Inhalational therapy represents the preferred mode of delivery for asthma medications. Nebulisers (for medications in solution) and metered-dose inhaler (MDI) with spacers are amongst the most widely used modalities.[2] Several studies have shown that MDI-spacers are as effective as, or better than, nebulisers in aerosol delivery in children.

A randomised study of children younger than 24 months of age (N = 123) who presented to an emergency department with mild-to-moderate wheezing was assessed for clinical improvement using the Modified Tal's Clinical Score, after drug delivery using nebuliser through MDI with spacer, which shows that the use of a MDI with spacer resulted in faster symptom relief with a statistically significant improvement at 1 h (odds ratio: 3.9, 95% confidence interval: 1.5–10.4).[3]

Nebuliser use requires a power supply, consumes more time, is not easily portable, is generally more expensive, requires maintenance and needs more supervision.[4] According to a study done in 2011, MDI spacers are portable easier to use, require less effort and time, do not require dose preparation or electricity for delivery and require lower medication doses compared to nebulisers.[5]

Objectives

  • To compare the clinical response to salbutamol delivered either by nebuliser or by MDI/spacer in children presenting with acute asthma of mild-to-moderate severity
  • To investigate the feasibility of changing the practice of using nebulisers for delivery of bronchodilators to using MDI with spacer for the same by studying side effects, utilisation of hospital resources (treatment preparation, delivery time and cost) and acceptability to patients.



  Methods Top


This prospective, single-blinded randomised control study was carried out in the emergency and outpatient units and inpatient wards of a large tertiary care centre in South India after obtaining approval from the institutional review board.

Children with a previous diagnosis of asthma or at least three episodes of wheeze presenting with mild-to-moderate exacerbation (Pulmonary Index Score [PIS]: 3–12) from October 2017 to March 2020 were included in the study. Children between 5 and 18 years of age were recruited after obtaining written consent from parents and assent from children above 7 years. Confidentiality was maintained. Children who had severe asthma exacerbation (Modified PIS [MPIS] of >12), those who had intensive care unit admission in the past for acute asthma or those who had difficulty to control asthma, those children with coexisting cardiac disease and those with intellectual disability/autism or other conditions, which make it difficult for them to learn MDI/spacer use, were excluded from the study.

Participants were randomly assigned to one of the two treatment groups. Randomisation was done in blocks of 10. Random table was computer generated and the allotment was concealed by enclosing the assigned group name in sealed covers which were numbered serially.

Instruments

The instrument comprised three sections.

The data collection pro forma comprised the age, sex, presenting complaints and medication history which helped to assess the relationship between the demographic variables, severity of symptoms and the clinical response to treatment.

The second section comprised the MPIS that was developed as an indicator of the severity of acute asthma in children. In the MPIS, six categories are evaluated: oxygen saturation, accessory muscle use, inspiratory-to-expiratory flow ratio, degree of wheezing, heart rate and respiratory rate. For each of these six measurements or observations, a score of 0–3 is assigned. The MPIS before and after the intervention was assessed to assess the clinical presentation before and after the intervention.

The third section comprised the cost of the treatment and duration and side effects, the patients' satisfaction of the treatment as measured against a Likert scale from 0 to 10 and also the time and electricity consumption for the equipment. This helped to compare the occurrence of side effects of the drug in the two treatment groups, the time spent by healthcare professional in preparing and administering the drug and the cost incurred (direct and indirect) in delivering the treatment.

Study protocol

There were two groups of study investigators. Principal investigator (PI) administered the treatment. The score assessors who assessed the MPIS were blinded to the treatment arm.

After obtaining the consent from parents and assent from children (if > 7 years), PI collected the baseline data including demographics, details of asthma treatment and details of the exacerbation. A standardised case form was used for data entry. The pre-score assessor calculated the MPIS prior to the treatment protocol and recorded in the observation sheet. PI then opened the sequentially numbered sealed cover, which contained the treatment allotment. These covers were previously prepared by statistician who generated random sequence using block randomisation (of 10). After obtaining the consent and allocating the groups, the children were seen by the clinician and were prescribed salbutamol, which is the main choice of drug for treating wheeze in children with asthma. Patients assigned to the treatment arm received salbutamol five puffs (0.5 mg) via the MDI, if they were <6 years and ten puffs (1 mg) if they were more than 6 years. Patients in the control group were given 0.5 ml (2.5 mg) salbutamol solution diluted with 4 ml 0.9% saline if <6 years and 1 ml (5 mg) salbutamol solution diluted with 4 ml 0.9% saline for children more than 6 years for inhalation using a nebuliser machine. After 10 min, the same score assessor again calculated MPIS, recorded in the observation card and enclosed that in a sealed cover. Assessors were blinded to the treatment which was administered in a separate room. PI was blinded to the score obtained till the stage of analysis.

The PI interviewed the parent and child regarding side effects, their perception of symptom improvement with treatment and ease of using the modality of drug delivery.

Outcome measures

The change in the MPIS after a single administration of bronchodilator route was the outcome in both the groups. The parent satisfaction scores and side effects after the drug delivery were also compared.

Data analysis

Totally 192 samples were needed in each arm for the actual study. However, with the pandemic and restriction in the use of nebulisers for fear of aerosol infection, we could not proceed with the study. An interim analysis of the available data is presented here. We believe the results of this analysis support the hypothesis and hence a total of 71 children were included, and out of that, only data of 68 samples were included in the final analysis. One sample was rejected since they did not fulfil the inclusion criteria, one sample did not give consent and left without receiving treatment and the data were not completely filled by one subject.


  Results Top


Comparison between the improvements in MPIS was analysed using independent t-test between the arms. The mean difference between the pre- and post-treatment in both the groups was assessed using paired t-test. Difference between the duration of treatment such as preparation time, delivery time, the cost of the treatment acceptability and satisfaction was assessed and reported using two independent-samples t-test. P < 0.05 was considered statistically significant.

[Table 1] denotes that there was a near equal distribution of study children in both the groups.
Table 1: Distribution of demographic and disease related characteristics

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The study findings infer that the MPIS within the groups before and after the intervention is highly significant with P < 0.001 [Table 2] and [Table 3]. Therefore, both modes of drug delivery were effective in improving the clinical outcome of children presenting with wheeze. However, the mean difference is higher in MDI with spacer which infers that it is effective in improving MPIS.
Table 2: Comparison of the improvement in the Modified Pulmonary Index Score within the experimental and control groups before and after the intervention

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Table 3: Comparison of mean difference in Modified Pulmonary Index Score between the control and experimental groups after the intervention

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The mean difference was significantly higher in the MDI group revealing that MDI is better in reducing distress and improving outcomes.

[Table 4] infers that a significantly higher number of children had tremors in the nebuliser group (P < 0.01). Children who were given inhaler therapy were satisfied with its use and also felt that the treatment relieved their symptoms of tremors (as observed), anxiety (as verbalised by the child) and headache (assessed using numerical scale) to a maximum extent compared to the nebuliser therapy with P < 0.001. 67.6% in the experimental group expressed that the inhaler was very easy to use and 76.5% were satisfied with the treatment and verbalised comfort with the inhalation therapy.
Table 4: Association of the mode of drug delivery with side effects, satisfaction and acceptability

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The study findings reveal that the mean duration for drug delivery for nebulisation was 13 min, whereas the mean duration of drug delivery for an inhaler was only 8 min which was significantly less (P < 0.001). The cost of the equipment was also less, and therefore, the overall cost of treatment using an inhaler is significantly less compared to a nebuliser (P < 0.001).


  Discussion Top


This study was done with the primary objective, to compare the MPIS in both the groups and compare the percentage of improvement in the PIS between the two groups at the end of administration of salbutamol. Studies have shown that MDI with spacer is as effective as nebulisers in the treatment of mild and moderate acute asthma exacerbations in the hospital setting.[6],[7]

The use of nebuliser has the advantage that it can be used without the cooperation of the child. The disadvantage of using a nebuliser is that the amount of salbutamol delivered to the lungs is less and a majority of the drug is lost and only about 10% of the drug reaches the lungs.[8],[9] The advantage of using a MDI is that it delivers a higher amount of drug to the lungs, which ranges from 10% to 40% as per studies.[10],[11] It has been noted in previous studies that children <5 years would need a face mask for effective drug delivery. In this study, none of the children found any difficulty in using MDI.

Both the treatment modes of delivery of the salbutamol drug was effective in treating and improving the clinical outcome in children presenting with mild-to-moderate severity of wheeze with P < 0.001. This can be compared to a hospital-based randomised control study carried out between March 2009 and December 2009 on children attending OP or casualty of Government Medical College, Alappuzha, with mild or moderate exacerbation of bronchial asthma where it was concluded that the efficacy of salbutamol in mild or moderate acute exacerbation of asthma was similar when the drug is delivered either by nebuliser or MDI with spacer.[3]

The second objective was to compare the occurrence of side effects of the drug in the two treatment groups, time spent for the procedure of administering the drug by two methods, the cost incurred in delivering the treatment and the ease of administration of both methods as per the patient perception.

Association was done between the mode of drug delivery and the intensity of side effects, presented by the subject, and it was found that the total duration of drug delivery through nebulization was with a mean value of 13 min, whereas the duration of drug delivery for an inhaler was only 8 min, which is comparatively less. It is heartening to know that the cost of the equipment was also invariably less, and therefore, the overall cost of treatment using MDI with spacer is relatively less compared to a nebuliser [Table 5]. The children who were given nebulisation had tachycardia and tremors compared to those given MDI with spacer. The children also expressed satisfaction with the use of MDI with spacer and also felt that the treatment relieved their symptoms to a maximum extent compared to the nebuliser therapy with P = 0.
Table 5: Association between the mode of drug delivery and the utilisation of hospital resources

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  Conclusion Top


The study concluded that the delivery of salbutamol by MDI with spacer is, as effective as delivery by nebuliser, in terms of clinical response and patient outcome. This study throws light over the selection of inhalational device over the conventional method which can have a major impact on resource utilisation in hospitals without compromising treatment benefits. Nebulisers can also have a significant impact on infection spread like in the COVID pandemic. The use of nebulisers is associated with a major risk for transmission, and therefore, the treatment guidelines have been shifted from using nebulisers to MDI with spacer for its limited risk in transmission during the COVID pandemic.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Bowton DL, Goldsmith WM, Haponik EF. Substitution of metered-dose inhalers for hand-held nebulizers. Success and cost savings in a large, acute-care hospital. Chest 1992;101:305-8.  Back to cited text no. 1
    
2.
Delgado A, Chou KJ, Silver EJ, Crain EF. Nebulizers vs. metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 months in a pediatric emergency department. Arch Pediatr Adolesc Med 2003;157:76-80.  Back to cited text no. 2
    
3.
Jose O. Comparison of clinical efficacy of nebulised salbutamol and salbutamol metered dose inhaler in children with mild or moderate exacerbation of bronchial asthma. Int J Contemp Pediatr 2017;4:741.  Back to cited text no. 3
    
4.
Kwok PC, Chan HK. Delivery of inhalation drugs to children for asthma and other respiratory diseases. Adv Drug Deliv Rev 2014;73:83-8.  Back to cited text no. 4
    
5.
Wildhaber JH, Dore ND, Wilson JM, Devadason SG, LeSouëf PN. Inhalation therapy in asthma: Nebulizer or pressurized metered-dose inhaler with holding chamber? In vivo comparison of lung deposition in children. J Pediatr 1999;135:28-33.  Back to cited text no. 5
    
6.
Selroos O. Dry-powder inhalers in acute asthma. Ther Deliv 2014;5:69-81.  Back to cited text no. 6
    
7.
Vangveeravong M. A comparative study of efficacy of salbutamol via metered dose inhaler with volumatic spacer and via dry powder inhaler, easyhaler, to nebulization in mild to moderate severity acute asthma exacerbation in childhood. J Med Assoc Thai 2008;91 Suppl 3:S115-23.  Back to cited text no. 7
    
8.
Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol 2000;29:264-9.  Back to cited text no. 8
    
9.
O'Callaghan C, Barry PW. How to choose delivery devices for asthma. Arch Dis Child 2000;82:185-7.  Back to cited text no. 9
    
10.
Dolovich MB, Dhand R. Aerosol drug delivery: Developments in device design and clinical use. Lancet 2011;377:1032-45.  Back to cited text no. 10
    
11.
Labiris NR, Dolovich MB. Pulmonary drug delivery. Part II: The role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol 2003;56:600-12.  Back to cited text no. 11
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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