OBJECTIVE: To determine whether nebulized 3% hypertonic saline with epinephrine is more effective than nebulized 0.9% saline with epinephrine in the treatment of bronchiolitis in the emergency department. DESIGN: Randomized, double-blind, controlled trial. SETTING:Single-center urban pediatric emergency department. PARTICIPANTS: Infants younger than 12 months with mild to moderate bronchiolitis. INTERVENTIONS: Patients were randomized to receive nebulized racemic epinephrine in either hypertonic or normal saline. OUTCOME MEASURES: The primary outcome measure was the change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS) from baseline to 120 minutes. The change in oxygen saturation was also determined. Secondary outcome measures included the rates of hospital admission and return to the emergency department. RESULTS:Forty-six patients were enrolled and evaluated. The 2 study groups had similar baseline characteristics. The RACS from baseline to 120 minutes demonstrated no improvement in respiratory distress in the hypertonic saline group compared with the normal saline control group. The change in oxygen saturation in the hypertonic saline group was not significant when compared with the control group. Rates of admission and return to the emergency department were not different between the 2 groups. CONCLUSIONS: In the treatment of acute bronchiolitis, hypertonic saline and epinephrine did not improve clinical outcome any more than normal saline and epinephrine in the emergency setting. This differs from previously published results of outpatient and inpatient populations and merits further evaluation. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN66632312.
RCT Entities:
OBJECTIVE: To determine whether nebulized 3% hypertonicsaline with epinephrine is more effective than nebulized 0.9% saline with epinephrine in the treatment of bronchiolitis in the emergency department. DESIGN: Randomized, double-blind, controlled trial. SETTING: Single-center urban pediatric emergency department. PARTICIPANTS: Infants younger than 12 months with mild to moderate bronchiolitis. INTERVENTIONS:Patients were randomized to receive nebulized racemic epinephrine in either hypertonic or normal saline. OUTCOME MEASURES: The primary outcome measure was the change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS) from baseline to 120 minutes. The change in oxygen saturation was also determined. Secondary outcome measures included the rates of hospital admission and return to the emergency department. RESULTS: Forty-six patients were enrolled and evaluated. The 2 study groups had similar baseline characteristics. The RACS from baseline to 120 minutes demonstrated no improvement in respiratory distress in the hypertonicsaline group compared with the normal saline control group. The change in oxygen saturation in the hypertonicsaline group was not significant when compared with the control group. Rates of admission and return to the emergency department were not different between the 2 groups. CONCLUSIONS: In the treatment of acute bronchiolitis, hypertonicsaline and epinephrine did not improve clinical outcome any more than normal saline and epinephrine in the emergency setting. This differs from previously published results of outpatient and inpatient populations and merits further evaluation. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN66632312.
Authors: Todd A Florin; Terri Byczkowski; Richard M Ruddy; Joseph J Zorc; Matthew Test; Samir S Shah Journal: J Pediatr Date: 2015-03-04 Impact factor: 4.406