Fever Signs and Symptoms Fever
Conditions
Interventions
1. Experimental group: A single dose (10 mg/kg) of Ibuprofen at zero time, followed by a single dose (15 mg/kg) of Acetaminophen at time = 4 hours
2. Control group: A single dose (10 mg/kg) of Ibuprof
Sponsors
American University of Beirut (Lebanon)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 6 months and 14 years 2. Rectal temperature greater than or equal to 38.8°C 3. Consent of treating physician 4. Consent of parent(s) and child if old enough to give consent (greater than 7 years) 5. No antipyretic intake for 8 hours prior to enrolment
Exclusion criteria
Exclusion criteria: 1. Presence of concurrent hepatic or renal disease 2. Chronic and/or serious disease such as malignancy, septic shock, malabsorption syndromes etc. 3. Any condition that may interfere with the absorption of the investigational drugs such as gastritis, diarrhoea, ileus etc. 4. Hypersensitivity to acetaminophen or ibuprofen 5. Bleeding disorder or tendency 6. Asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the proportion of children in each group, with body temperature of 37.8°C or less at time 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the proportion of children in each group, with body temperarures of 37.8°C and below, at times 7 and 8 hours, and the change in hourly temperature from baseline, at times 4, 5, 6, 7, 8 hours. The proportion of patients in each group with any immediate adverse effect (within 24 hours from administration) that may be related to either drug, such as gastrointestinal bleed, hypothermia or others. | — |
Countries
Lebanon
Outcome results
None listed