Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 4

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 description: 
      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
      response, under different circumstances it has the potential to be harmful. Fever increases
      the metabolic rate approximately 10% for every 1 degree C rise in body temperature. The
      myocardial depression,orthostatic dysfunction, and increases in oxygen consumption,
      respiratory minute volume, and respiratory quotient that occur may not be tolerated by all
      patients including some children.

      Because of the ubiquitous nature of the problem, childhood fever, this study has the
      potential to immediately impact the way clinicians and parents treat children with fever. If
      the combination regimens are not shown to be superior, it could limit improper medication
      administration and overdose. If it is superior, the combination of medications may improve
      other symptoms associated with fever such as discomfort. Either way, it will fill the gap
      that exists in the evidence-based approach to the management of childhood fever and
      immediately impact current practice.
    

Intervention name(s): Acetaminophen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Given for fever control 15mg/kg; Given for fever control 10 mg/kg
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fever treatment; children