Proparacaine vs Placebo for Corneal Injuries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-09-30

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.

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Detailed Description

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Conditions

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Corneal Abrasions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Proparacaine drops 0.05%

Intervention Type DRUG

topical, 0.05% drops, PRN continuously for up to 7 days

2

placebo drops on a PRN basis for up to 7 days post injury

Acetaminophen with Codeine for breakthrough pain

Gatifloxacin drops

Group Type PLACEBO_COMPARATOR

saline drops

Intervention Type DRUG

saline drops continuously PRN for up to 7 days

Interventions

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Proparacaine drops 0.05%

topical, 0.05% drops, PRN continuously for up to 7 days

Intervention Type DRUG

saline drops

saline drops continuously PRN for up to 7 days

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No