A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
Overview
- Phase
- Phase 3
- Intervention
- Acetaminophen
- Conditions
- Fever
- Sponsor
- Kaiser Permanente
- Enrollment
- 374
- Locations
- 1
- Primary Endpoint
- Fever >=38C Within 32 Hours of Vaccination.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.
Detailed Description
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Child is a current Group Health enrollee.
- •Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.
Exclusion Criteria
- •If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
- •If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.
Arms & Interventions
Acetaminophen
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Intervention: Acetaminophen
Placebo
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Intervention: placebo
Outcomes
Primary Outcomes
Fever >=38C Within 32 Hours of Vaccination.
Time Frame: Fever within 32 hours following vaccination
Fever, defined as rectal temperature \>=38C within 32 hours of vaccination.
Secondary Outcomes
- Infant Time Lost From Sleep(On the night following vaccinations)
- Parent Time Lost From Sleep(On the night following vaccinations)
- Study Assignment Unblinded(At any time during participation in the study)
- Infant Fussiness(Within 32 hours of vaccination)
- Fever >=39C Within 32 Hours of Vaccination.(Fever within 32 hours following vaccination)
- Medical Utilization(Within 32 hours of vaccination.)
- Parent Time Lost From Work(Through the day after vaccination)