Phase 4
Completed N=60
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Source: ClinicalTrials.gov NCT00267293 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Child Temperature (Degrees C)Over 6 Hours — 38.5; 37.2; 36.9 degrees Celcius — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Temperature (Degrees C)Over 6 Hours |
38.5; 37.2; 36.9 | <0.001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00267293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.