Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
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.
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.
Inclusion Criteria:

 -  Age 6 months - 7 years of age at time of the fever.

 -  Initial temperature of 38.0C (100.4F) or more.

 -  Ability to cooperate with serial temporal artery temperature measurements.

 -  Ability to take medications by mouth.

 -  Willingness of the child's guardian/sponsor to give informed consent

 Exclusion Criteria:

 -  Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen,
 aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of
 presentation.

 -  Patients >=3 years of age that have received narcotics in the previous 24 hours.

 -  Children with weight >60 kg. Treatment of children with weights >60 kg will result in
 greater than recommended adult doses of the medications.

 -  History of adverse reaction to any study medication ingredient.

 -  History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or
 thrombocytopenia.

 -  Presence of moderate or severe dehydration.

 -  Inclusion in the trial on 3 previous occasions

 -  Medical judgment that the severity of the underlying illness prohibits inclusion.