Efficacy of xylometazoline nasal spray in reducing bleeding and nasal symptoms in pateints after septoplasty; A randomized controlled trial

Xylometazoline-Hydrochloride (0.1%) versus Normal Saline in Reducing Postoperative Bleeding and Symptom Control in Post-Septoplasty Patients: A Randomized Controlled Trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000921381

Enrollment

Registered

2026-07-27

Start date

2026-08-17

Completion date

2026-10-31

Last updated

2026-08-03

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

Conditions

None listed

Brief summary

This double-blinded randomised controlled trial aims to compare the efficacy of 0.1% xylometazoline-hydrochloride nasal spray versus 0.9% isotonic saline nasal spray in reducing postoperative bleeding and nasal symptoms following septoplasty. Eighty patients aged 18–60 years undergoing elective septoplasty for deviated nasal septum at Benazir Bhutto Hospital, Rawalpindi will be randomly assigned to either xylometazoline or saline spray, administered once per nostril twice daily for 7 days. Postoperative bleeding, nasal obstruction, pain, and endoscopic findings including nasal edema, crusting, discharge, scarring and adhesions will be assessed at Day 7. It is hypothesised that xylometazoline will significantly reduce postoperative bleeding and other nasal symptoms compared to saline.

Interventions

0.1% xylometazoline-hydrochloride nasal spray, one spray per nostril, twice daily (morning and evening), for 7 days, administered by the patient at home following elective septoplasty. Patients will be provided with a printed checklist for the seven days that they will be required to fill in and bring along at follow-up. Adherence will be checked on a patient-reported basis on the basis of that checklist.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Patients aged 18–60 years undergoing elective septoplasty for symptomatic deviated nasal septum (DNS) 2. No history of chronic rhinosinusitis, allergic rhinitis, nasal trauma, or prior nasal surgeries 3. Willing to comply with the 7-day nasal treatment regimen

Exclusion criteria

1. History of allergic reactions to xylometazoline or saline 2. Use of antihistamines, steroids, or anticoagulants within the past 2 weeks 3. Pregnancy or breastfeeding 4. Underlying bleeding disorders or immunocompromised conditions 5. Patients undergoing combined nasal procedures (e.g., Functional Endoscopic Sinus Surgery, turbinate reduction)

Outcome results