Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT00267293
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
7 Years
Study:
NCT00267293
Study Brief:
Protocol Section:
NCT00267293