CompletedPhase 2ACTRN12619001394134

The Effects of Oxymetazoline Nasal Spray after Dacryocystorhinostomy Among Adult Patients

A Randomized Controlled Trial on the Effects of Oxymetazoline Nasal Spray after Dacryocystorhinostomy


Sponsor

University of the Philippines Manila - Philippine General Hospital

Enrollment

20 participants

Start Date

Jun 1, 2017

Study Type

Interventional

Conditions

Summary

The study aimed to determine the effect of oxymetazoline nasal spray after dacryocystorhinostomy, specifically: to compare the success of fistula formation with oxymetazoline versus placebo, and to compare the incidence of post-operative congestion, pain and bleeding with oxymetazoline versus placebo. The intervention group used oxymetazoline, while the placebo group used sodium chloride. The researchers hypothesized that after DCR, oxymetazoline nasal spray does not significantly decrease nasal discomfort compared to placebo. The researchers also hypothesized that after DCR, oxymetazoline nasal spray does not significantly improve fistula formation compared to placebo.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Adult patients (>18 y/o) of sound mind who can consent for the study, diagnosed with primary acquired NLDO with clearance for external DCR under general anesthesia, and assessed with pre-operative nasal endoscopic evaluation as suitable by Investigator 3.For cases with bilateral obstruction, only one side was included in the study.

Exclusion Criteria1

  • The patients with the following characteristics were excluded from the study: previous lacrimal or nasal surgery; active inflammation of the lacrimal apparatus or nasal passages; known case of uncontrolled hypertension, diabetes or hyperthyroidism; use of monoamine oxidase inhibitor or tricyclic antidepressants; known allergy to oxymetazoline; or breastfeeding patients.

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Interventions

The intervention group used 0.05% oxymetazoline nasal spray post-operatively, instilled twice a day (8AM and 8PM), on the operated side for the first 3 days. The administration of the medication was d

The intervention group used 0.05% oxymetazoline nasal spray post-operatively, instilled twice a day (8AM and 8PM), on the operated side for the first 3 days. The administration of the medication was done by a separate single investigator while the patient was admitted in the hospital ward to ensure adherence.


Locations(1)

Manila, Philippines

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ACTRN12619001394134