Proparacaine vs Placebo for Corneal Injuries

Study Overview
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Brief Summary
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Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries. Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada. Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain. Patients were instructed to use the study drug on an as-needed basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected. The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.

Official Title
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Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries

Conditions
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Corneal Abrasions

Intervention / Treatment
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* Drug: Proparacaine drops 0.05%
* Drug: saline drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with acute (within 24 hrs) traumatic corneal injuries Exclusion Criteria: immunocompromised known allergy to local anesthetic unable to consent /follow instructions for dosing / go to follow-up appointments previous ocular pathology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients randomized to 0.05% Proparacaine drops on a PRN basis for up to 7 days Acetaminophen with Codeine for breakthrough pain topical Gatifloxacin drops | Drug: Proparacaine drops 0.05%<br>* topical, 0.05% drops, PRN continuously for up to 7 days<br>|
| Placebo Comparator: 2<br>placebo drops on a PRN basis for up to 7 days post injury Acetaminophen with Codeine for breakthrough pain Gatifloxacin drops | Drug: saline drops<br>* saline drops continuously PRN for up to 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction |  | continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | at 5 days post injury | 
| delayed wound healing |  | days 3,5 ,7 postinjury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cornea, analgesia, topical, anesthetic