Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?

Conditions

• Dacryocystitis
• Dacryostenosis
• Epiphora

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Proparacaine Hydrochloride ophthalmic solution, USP 0.5% — DRUG
  One drop instilled in one eye, randomly chosen, as topical anesthetic
• Balanced salt solution — DRUG
  One drop instilled in one eye, randomly chosen, as control placebo

Study Details

Purpose: It is unknown whether instillation of a drop of anesthetic ophthalmic solution into the eye such as proparacaine hydrochloride 0.5% prior to probing and irrigation of the tear duct (lacrimal drainage) system improves participant comfort during the procedure. To date, there have been no formal studies evaluating the possible benefit of this pretreatment. Methods: Participants 18 years and older who present to the Louisiana State University or associated outpatient ophthalmology clinic(s) with a complaint of epiphora (excessive tearing) who necessitate bilateral lower lid probing and irrigation of the lacrimal drainage system will be enrolled in the study. One eye will be randomized to receive a drop of the anesthetic Proparacaine hydrochloride 0.5% and the other eye will receive a control drop of Balanced Salt Solution (BSS). Probing and irrigation will then be performed in the usual fashion. The participant will then be questioned via survey on a pain scale of 1-5 as to the amount of subjective pain experienced on each side during the procedure. Expected Results: Investigators expect participants will experience statistically significantly less pain in eyes that have received a drop of Proparacaine hydrochloride 0.5% prior to performance of probing and irrigation compared to the eyes which have received the control drop.

Key Dates

Start date

Jun 30, 2020

Status verified

Dec 2022

Primary completion

Dec 30, 2022

Completion

Jan 31, 2023

Study Design

Enrollment

145 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants with no obstruction of the lacrimal system
  Patients will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in one eye and a drop of BSS in the other eye prior to probing and irrigation.
• Experimental: Participants with obstruction of the lacrimal system
  Participants who have a blockage in their tear drainage system on probing and irrigation. Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in one eye and a drop of BSS in the other eye prior to probing and irrigation.

Primary Outcome Measure

Association between reduction of pain/discomfort and anesthetic use [ Time Frame: 1 minute ]

Central Contacts

• Austin M Pharo, MD
  (504) 568-3156
  [email protected]

Locations (1)

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