The Effect of Montelukast on Prevention of Nasal Polyps Recurrence Following Functional Endoscopic Sinus Surgery.

Determining the effect of Montelukast on the prevention of nasal polyp recurrence after endoscopic functional sinus surgery

Clinical trial with an intervention group, phase 3, sample size 69, with a parallel group; One side blind, randomized using block randomization

This study is conducted in Razi Birjand Hospital, South Khorasan Province. 138 patients were randomly divided into two intervention groups, one or two (A-B). Questions related to the effectiveness of the intervention before and 6 weeks after the treatment will be asked and evaluated by the moderator.

Patients with chronic rhinosinusitis will be referred to the Otolaryngology Clinic of Razi Birjand Hospital in 2023. The inclusion criteria include: age over 18 years, taking medication regularly, consent to participate in the study, cooperation with the present research team, candidate for endoscopic sinus surgery. Exclusion criteria include: patients with exacerbation of recurrent acute rhinosinusitis, rhinosinusitis without polyposis, sinusitis associated with ciliary dyskinesia or sinusitis associated with cystic fibrosis.

The intervention groups are as follows: Group A receiving Montelukast 10 mg once a day at night and Group B receiving a topical steroid such as fluticasone 0.1 mg twice a day, 50 micrograms each time.

Runny nose, improvement of symptoms compared to before taking the drug, clinical symptoms include: headache, nasal congestion, sinus pain, PND, pain around the eyes, pus in the nose, cough, runny nose and decreased sense of smell

The placement of people in each group will be randomized in a simple and blocked way, in one of the two groups A (receiver of Montelukast 10 mg tablets daily, one at night), intervention B (receiver of a topical steroid such as fluticasone 0.1 mg twice a day (50 micrograms each time) will be placed. In this way, first, various blocks of four are created on different cards (AABB, BBAA, ABAB, BABA, ABBA, BAAB). One of these blocks will be randomly selected and the patients will be divided into one of two groups A or B. Then randomization will be done for other patients as well.

Outcome evaluator: The study administrator, without knowing the type of drug received, asks questions from the patients and records them in the relevant checklist.