Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267293
Status:
COMPLETED
Last Update Posted:
2012-05-09
First Post:
2005-12-16
Brief Title:
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently when a child has fever either ibuprofen eg Motrin Advil or acetaminophen eg 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 depressionorthostatic 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
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 depressionorthostatic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None