Comparison of the effect of salbutamol and inhaled epinephrine and 5% hypertonic saline on reducing the severity of symptoms and duration of hospitalization of infants with bronchiolitis

Determining the effect of 5% salbutamol, epinephrine and saline hypertonic saline on the treatment of infants with bronchiolitis

Clinical trial with three intervention groups, with parallel groups, double-blind, randomized, phase 3 on 45 infants. The Randomizer Software will be used for randomization.

Eligible infants after randomization were divided into three groups and the first group was 2.5 mg / kg body weight of salbutamol every 4 hours via nebulizer and the second group epinephrine via nebulizer at 0.5 mg / kg, and the third group of 5% Nacl at 3 cc in 0, 30 and 60 minutes

In this study, infants from 2 months to 24 months referred to Taleghani Educational and Medical Center who have symptoms of bronchiolitis and a respiratory score of 4 or higher based on Pediatric respiratory severity will be included. In contrast to infants born prematurely and hospitalized during the first two months of life, people with a history of chronic cardiopulmonary disease or hypersensitivity and drug reactions to salbutamol, epinephrine, and hypertonic saline, or those before Hospitalized for bronchodilators and corticosteroids will not be included in the study

In this study, there are three intervention groups: group A users of inhaled salbutamol, group B users of inhaled epinephrine and group C users of inhaled hypertonic saline solution.

Severity of clinical symptoms including respiratory distress, skin color, general mood, number of breaths, body temperature, and auscultation by physician

After obtaining informed consent from the parents of eligible infants, their allocation to each of the three groups receiving salbutamol inhaler (a), inhaler epinephrine (b) and saline recipient Inhalation hypertension (c) will occur randomly. For this purpose, the Randomizer Software will be used. based on the software output, the enterance sequence of participants will be written in advance by one of the members of the research team on cards with the letters a, b, and c and will be placed in sealed and numbered envelops. Once the eligibility of the infants is determined based on the inclusion and exclusion criteria, the numbers listed on the envelope will be determined in each of the groups.For example, for the first infant, envelope number 1 is opened and according to the letter in that group, the intervention will be specified and the desired intervention will be applied. Due to the fact that the sequence of entry of individuals by a person other than the person responsible for the intervention will be specified and placed in sealed envelopes, the process of entry of infants into each of the intervention groups will remain secret until the envelopes are opened.

In this study, the infant's parents, the person responsible for the intervention, and the person evaluating the outcome of the intervention will be kept unaware of how people are placed in the groups. In this way, the process of entering the groups will be determined in advance by one of the members of the research team and will be placed in numbered envelopes in the package. For this reason, when the infant is found to be eligible according to the inclusion criteria, the person responsible for the intervention (first physician) and the parents will be unaware of the type of intervention received (three intervention groups).After obtaining the consent of one of the envelopes, the numbers will be opened in order, and only at this stage it will be determined in which group the child will be placed. It should be noted that in this study, infants will be visited by two independent physicians. The first physician after assigning the child to the groups to apply the intervention and the second physician 24 and 48 hours after the intervention to evaluate the response to treatment. For this reason, both the intervention practitioner and the physician are responsible for evaluating the outcome of the intervention (response to treatment) and are unaware of the allocation.