A Phase 4 interventional study of Acetaminophen and Ibuprofen in Fever, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 6 Months to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-09.
Sponsored by Penn State University · Phase 4, Interventional, and Treatment
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.
601 studies on the registry are indexed under Fever; 102 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 382 interventional studies indexed under Fever.
Browse Fever studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg)
Drug: Ibuprofen
At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and an appropriate dose of Acetaminophen (15 mg/kg)
Drug: Acetaminophen · Drug: Ibuprofen
At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and at time 3 hours is given an appropriate dose of Acetaminophen (15 mg/kg)
Drug: Acetaminophen · Drug: Ibuprofen
Given for fever control 15mg/kg
Given for fever control 10 mg/kg
Child Temperature (Degrees C)Over 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.
Time frame: 6 hours
| Milestone | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 |
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.
| degrees Celcius | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen |
|---|---|---|---|
| Child Temperature (Degrees C)Over 6 Hours | 38.5 ± 1.5 | 37.2 ± 0.6 | 36.9 ± 0.3 |
Collected over 6 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Ibuprofen Alone | — | 0/20 (0%) | 0/20 (0%) |
| Group B: Ibuprofen and Acetaminophen | — | 0/20 (0%) | 0/20 (0%) |
| Group C: Ibuprofen Then Acetaminophen | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen | Total |
|---|---|---|---|---|
| <=18 years | 20 | 20 | 20 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age Continuous(years) | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen | Total |
|---|---|---|---|---|
| Mean | 3.2 ± 1.9 | 3.0 ± 1.9 | 4.0 ± 2.8 | 3.4 ± 2.2 |
| Sex: Female, Male(Participants) | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen | Total |
|---|---|---|---|---|
| Female | 8 | 10 | 13 | 31 |
| Male | 12 | 10 | 7 | 29 |
| Region of Enrollment(participants) | Group A: Ibuprofen Alone | Group B: Ibuprofen and Acetaminophen | Group C: Ibuprofen Then Acetaminophen | Total |
|---|---|---|---|---|
| United States | 20 | 20 | 20 | 60 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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