Efficacy and Safety of Pediatric Drugs in Nasal Congestion

Recruitment & Eligibility

Inclusion Criteria

Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
Signed Consent;
Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).

Exclusion Criteria

Participation in clinical trial in the year prior to this study;
Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
Infectious bacterial-disease (clinically diagnosed);
Participants treated with antibiotic or possible antibiotic use due to another medical condition;
Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
History of hyperthyroidism or hypertension;
History of hypersensitivity to the components of the study drugs;
History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
Exclusive mouth-breathers patients;
Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
History of alcohol and / or drug abuse 3 months prior to the study;
Smokers
Pregnancy or risk of pregnancy and lactating patients;
PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.

Study & Design

Arm && Interventions

Group	Intervention	Description
Naridrin	Naridrin	Naridrin: 2 drops in each nostril once daily as prescription
0.05 % Oxymetazoline Hydrochloride	Afrin	2 pumps in each nostril every 12 hours

Primary Outcome Measures

Name	Time	Method
Relief of Nasal Congestion	2 days	Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	2 days	Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up. The evaluation of the heart frequency will also be a safety parameter.

Recruitment & Eligibility