Fever
Conditions
Keywords
Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections
Brief summary
The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.
Interventions
Diclofenac potassium
DRUGAcetaminophen
Acetaminophen
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections * Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study
Exclusion criteria
* History of hypersensitivity to any drugs or excipients of the study * Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications * Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding * Neurological and hemodynamics disorders * Evidence of liver or kidney impairment or heart failure * Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours) * Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Reduction of Temperature | 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach a Reduction of Temperature as 0.5 and 1 °C | 2 hours |
| Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours | 6 hours |
| Safety of Diclofenac Potassium Therapy in the Study Period | 6 hours |
| The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever | 2 hours |
Countries
Venezuela
Participant flow
Recruitment details
2 participants entered the study but did not receive drug because drug was not available in the region. The study was then terminated.
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Potassium This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region | 0 |
| Acetaminophen This study was cancelled. No patients were enrolled in this group. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Drug not available. | 2 | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment Venezuela | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Reduction of Temperature
Time frame: 2 hours
Secondary
Safety of Diclofenac Potassium Therapy in the Study Period
Time frame: 6 hours
Secondary
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Time frame: 2 hours
Secondary
Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Time frame: 2 hours
Secondary
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Time frame: 6 hours