Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?
Condition: Epiphora; Dacryostenosis; Dacryocystitis
MeSH terms: Lacrimal Apparatus Diseases; Dacryocystitis
Intervention: Proparacaine Hydrochloride ophthalmic solution, USP 0.5%; Balanced salt solution
Intervention description: One drop instilled in one eye, randomly chosen, as topical anesthetic; One drop instilled in one eye, randomly chosen, as control placebo
Intervention MeSH terms: Proxymetacaine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blinded, randomized, controlled clinical trial with one eye of each participant receiving the experimental treatment and one eye acting as control, receiving placebo
Masking: Double (Participant, Care Provider)
Masking description: Randomization will be performed by the primary investigator who will have no participant interaction during the performance of the procedure and obtainment of the survey responses. A random number generator will be used to obtain either an even or odd number. Odd numbers mean the left eye receives Proparacaine hydrochloride 0.5% ophthalmic solution, even numbers mean the right eye does. The chief investigator will instruct clinic personnel as to which syringe should be labeled "L" or "R" depending on randomization results.Two identical 1 ml syringes will be prepared. One syringe containing control BSS, and the other containing Proparacaine hydrochloride 0.5% ophthalmic solution. Each syringe will be labeled by clinical assistants with either left (L) or right (R) as randomized.
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasolacrimal duct obstruction; Probe and irrigation

Summary:

      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 William Beaumont Hospital - Royal
      Oak, Michigan outpatient ophthalmology clinic with a chief 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of any sex aged 18 years or older

          -  Signs and symptoms of epiphora which necessitate performance of a diagnostic probing
             and irrigation of the bilateral lower eyelid lacrimal drainage system at Beaumont
             Royal Oak or any of the listed physician offices who present with a chief complaint of
             epiphora from either eye

        Exclusion Criteria:

          -  A known allergy to topical proparacaine hydrochloride

          -  Known pre-existing scarring, surgery, radiation to the nasolacrimal system

          -  Presence of blockage and or reflux on probing and irrigation of either side

          -  Cognitive Impairment