None listed
Conditions
Interventions
Group 1 Type of group
Nimesulide suspension 1.7 mg / Kg dose every 8 hours. (50 mg / 5 ml), during the entire treatment. Maximum dose 100 mg / day.
Group name:Group 2 Type of group
Diclofenac suspension 0.5 mg / Kg dose every 8 hours. (9 mg / 5 ml), during the entire treatment. Maximum dose 2 mg / day.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients between 3 and 5 years of age. • At the time of admission, patients must have an expectation of survival with effective therapy and regular medical care during the study. • Patients must be willing to complete all activities related to the study. The patient´s parent / legal guardian will arrange for the patient to return to all required visits, and will respond to all questions regarding adverse events. • Be able to receive medication orally. • High uncomplicated respiratory infection: Acute disease: Nasal congestion, rhinorrhea, sneezing, malaise, sore throat, fever, cough, otalgia and hoarseness with a time of illness less than 48 hours and without signs of suppuration.
Exclusion criteria
Exclusion criteria: • Presence of previous systemic disease, compromise of the general state and signs of general danger. • Allergic rhinitis, bronchial hyperreactivity. • Presumed infection of human immunodeficiency virus. • Hypersensitivity to NSAIDs or to one of the excipients in the formulation of both drugs • Previous access to this protocol or another protocol. • Concurrent use of another medication under investigation • Chronic corticotherapy or having received deposit corticoid. • Patients with body weight greater than 20 Kilos. • Concurrent use of antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:We will proceed to the analysis of the data concerning pain. The pain will be registered through the OUCHER scale Measure:Clinical Outcomes of the Patient Timepoints:Days 3 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Global Patient Outcome Timepoints:At the end of the treatment ; Outcome name:Clinical evaluation of signs and symptoms. The summaries will show the number of patients with each sign and symptom evaluated, with the percentage in each result category Measure:Clinical Signs and Symptoms Timepoints:During the treatment ; Outcome name:At each assessment point a summary statistic (by treatment group) will be provided to reflect the change from baseline pain. Measure:Body temperature and pain assessment Timepoints:During the treatment | — |
Outcome results
None listed