Evaluation of the use of a nasal spray containing a small amount of seawater, after nasal surgery and its impact on improving the quality of life of patients

Evaluation of the use of a nasal spray solution of sodium chloride 0.9% in the immediate postoperative septoplasty and turbinecotomy and its impact on quality of life of the patient

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-5bxqm5

Enrollment

Unknown

Registered

2015-02-10

Start date

2014-05-30

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal obstruction

Interventions

Experimental group: 53 patients undergoing post turbenectomy and septoplasty hold the nasal spray solution of sodium chloride 0.9% 6 times a day until the end tube tablets containing 500mg paracetamol

Drug

D01.210.450.150.875

D02.065.199.092.040

D02.033.100.624.853

D04.808.745.432.769.795

E02.319.267.080

E02.319.267.100

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Both sexes; between 18-65 years; indication for surgery septoplasty and inferior bilateral turbinectomy with dislocation of the turbinate; agreement to abide by the procedures and requirements of the test and attend to the Office (s) day (s) and time (s) given (s) for the evaluations

Exclusion criteria

Exclusion criteria: Use of other nasal decongestant; use of analgesics and corticosteroids not described in the protocol; hypersensitivity (allergy) to components of the formula; use of topical medication in the nasal region; pregnant and lactating women; drinking alcohol during treatment; another surgery associated; Use of Gelfoan; packing and splints; Patients who have had surgery under general anesthesia; other medical conditions considered by the investigator as reasonable for the disqualification of the individual participate in the study; postoperative complications (septal hematoma, heavy bleeding or tamponade requiring return to the operating room or infection).

Design outcomes

Primary

Measure	Time frame
Decreased crust formation and mucosal edema and increased ease of removal of the crust in the test group by applying a questionnaire after 3 and 10 days of surgery from the observation of variation of at least one point in clinical scale questionnaire	—

Secondary

Measure	Time frame
Evaluate the safety of the investigational product through causal analysis of reported adverse events throughout the study	—

Countries

Brazil

Contacts

Public ContactCamila ;Marina Abreu;Fagundes

Farmoquimica S.A;Hospital IPO - Hospital Paranaense de Otorrinolaringologia

cabreu@fqm.com.br;ma.serrato@hotmail.com+55 21 21226100 ;(41) 3314-1500

Outcome results

None listed

Source: REBEC (via WHO ICTRP)