Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
Status:
Completed
Trial end date:
2016-02-29
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to compare the effectiveness of nebulized hypertonic
saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess
whether non-responders to initial therapy benefit from continuation of the same therapy.
This trial was conducted at a tertiary care teaching hospital over a period of one year in
children with bronchiolitis presenting to the out-patient department and emergency. After
obtaining a signed informed consent from the parents, all eligible children were assessed for
baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial
blood gas analysis where ever required.
Computer generated random numbers were used for enrolment in consecutive manner and patients
were randomly assigned into two groups. The first group received one dose (4ml) of nebulized
hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline
diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing,
antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.
All children were reassessed 20 minutes after one dose of nebulization using the clinical
score and a child was labelled as a "responder" if he showed an improvement in the clinical
severity score by atleast 3 points after 20 minutes of nebulization. Both responders and
non-responders were given a repeat dose of nebulization according to the group to which the
child had been randomized, if: a) Severe audible wheeze with severe respiratory distress
(severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min.
Non responders were given a maximum of three continuous doses of nebulization.
Child was considered fit for discharge if he/she was feeding well orally, there was no need
for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on
room air for a period of more than 12 hours.