Efficacy of 0.1% Xylometazoline-Hydrochloride Nasal Decongestant Spray in Postoperative Sign/Symptom Relief Following Septoplasty: A Randomized Control Trial.

Abstract

Objective:This study evaluated the efficacy of 0.1% xylometazoline-hydrochloride nasal decongestant spray compared to 0.9% saline nasal spray in relieving post-septoplasty clinical nasal findings and symptoms. Methods: This triple-blinded randomized-clinical-trial was conducted in 2 tertiary-care hospitals in Karachi-Pakistan. A total of 120 septoplasty patients were recruited from June 20, 2022, to June 20, 2023. Randomly equally-assigned participants received either 0.9% isotonic-saline (control group) or 0.1% xylometazoline-hydrochloride (intervention group) nasal sprays. Participants were instructed to use nasal sprays for 1 week, twice daily, with a 12 hour interval between the 2 doses as a single spray per nostril. Follow-up assessments were conducted on days 3 and 7 after surgery. Postoperative symptoms, nasal-endoscopic findings, adverse-effects, and patient satisfaction were compared using Chi-square test and a P value of <.05 was considered significant. Results: Of 120 participants, 106 were analyzed with 53 participants in each group. By the end of third postoperative day, intervention group exhibited significantly lower rates of self-reported symptoms, including bleeding (7.5%:54.7%), nasal obstruction (3.8%:45.3%), headache (1.9%:30.2%), pain (3.8%:7.5%), as well as clinical nasal findings, including nasal edema (1.9%:58.5%), crusting (11.3%:58.5%), nasal discharge (9.4%:22.6%), and nonhealed scarring (18.9%:58.5%), compared to control group (P value < .001). On the seventh day, intervention group exhibited absence of self-reported symptoms and clinical nasal findings, whereas control group still experienced moderate symptoms (P value < .001). Intervention group had significantly higher patient satisfaction (P value < .001). Conclusions: Xylometazoline spray is highly effective in relieving post-septoplasty clinical nasal findings and symptoms, without adverse effects, indicating potential for wider clinical utilization.Trial Registration: UMIN Clinical-trial-registry: UMIN000052217. (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059598).