Clinical Trial: Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Brief Summary: Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.

Detailed Summary:

Despite a lack of evidence to support their fears, a majority of parents, pediatricians, and pediatric nurses believe that fever can be dangerous to a child. This "fever phobia" has caused a majority of caregivers to aggressively treat fever with antipyretics such as ibuprofen and acetaminophen, often in combination. Although there is scant data to support the use of these medications together for fever control and none using alternating regimens, it was recently reported that 50% of pediatricians and 70% of pediatricians with less than 5 years of experience advise parents to alternate acetaminophen and ibuprofen as an attempt to achieve maximal antipyresis. While a combination of aspirin (no longer used for antipyresis in children) and acetaminophen has been shown to be superior to either agent alone for fever reduction, these data cannot be extrapolated to the pairing of ibuprofen and acetaminophen.

There is evidence that combinations of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are more effective for the treatment of pain and can reduce opioid use when compared with a single agent. Improved activity and alertness in children have been reported after antipyretic administration.

It is believed that acetaminophen and ibuprofen may be safely used together because the two medications have significantly different pathways of metabolism that are not affected by each other, and have been used abroad in combination form for over a decade. Both acetaminophen and ibuprofen have been shown to be safe when given individually or together in recommended doses for short term use. There are no reports of adverse effects from combination therapy with standard doses.

In addition, while it now appears that fever itself is probably a protective physiologic re
Sponsor: Penn State University

Current Primary Outcome: Child Temperature (Degrees C)Over 6 Hours [ Time Frame: 6 hours ]

Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.


Original Primary Outcome: Determine if combination and alternating regimens of ibuprofen and acetaminophen are superior to ibuprofen alone for fever reduction.

Current Secondary Outcome:

Original Secondary Outcome:

  • Determine if combination and alternating regimens of antipyretics are superior for improvement of the discomfort associated with febrile illnesses in childhood.
  • Determine if combination and alternating regimens of antipyretics are as well tolerated as a single agent.


Information By: Penn State University

Dates:
Date Received: December 16, 2005
Date Started: January 2006
Date Completion:
Last Updated: May 8, 2012
Last Verified: May 2012