The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary hypothesis that in preschool children 12-59 months of age with persistent asthma on standardized asthma therapy, the number of asthma exacerbations requiring systemic corticosteroids will be more frequent in children randomized to receive acetaminophen as compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.
AVICA is a 48-week randomized therapeutic trial involving two parallel treatment arms: acetaminophen and ibuprofen. Participating children will be randomized to receive either acetaminophen or ibuprofen administered as needed per parental decision for fever and analgesia. This study will address which is the most appropriate antipyretic-analgesic medication in young children with asthma, and will inform both clinicians and parents seeking to treat children with fever and pain. Given the high frequency of administration of these drugs, this study will have a significant impact on pediatric healthcare regardless of whether a differential effect is discovered as significant uncertainty currently exists as to whether acetaminophen use is associated with increased asthma symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
15 mg/kg every 6 hours as needed
9.4 mg/kg every 6 hours as needed
University of Arizona College of Medicine
Tucson, Arizona, United States
Children's Hospital & Research Center Oakland
Oakland, California, United States
Exacerbation Frequency
the number of asthma exacerbations requiring systemic corticosteroids
Time frame: last 46 weeks of 48 week treatment period
Asthma Control Days
proportion of study days on which asthma was controlled, measured by electronic diary
Time frame: last 46 weeks of 48 week treatment period
Asthma Rescue Medication Use
average albuterol rescue use per week, measured by electronic diary
Time frame: last 46 weeks of 48 week treatment period
Health Care Utilization
frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma
Time frame: last 46 weeks of 48 week treatment period
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UCSF Benioff Children's Hospital
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
...and 5 more locations