NCT00622817

The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis

Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Schneider Children's Medical Center, Israel · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

Summary

This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis. The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis. Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002) Patients: 65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005. The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score\>7 with a range scale 0-10).

Detailed description

All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge. Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DRUG	xylometazoline HCL 0.05%	Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
DRUG	Epinephrine 1mg	Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2008-02-25
• Last updated: 2008-02-26