None listed
Conditions
Brief 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.
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 done by a separate single investigator while the patient was admitted in the hospital ward to ensure adherence.
Sponsors
University of the Philippines Manila - Philippine General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed