Proparacaine vs Placebo for Corneal Injuries

Phase 1

Completed

• Conditions: Corneal Abrasions
• Interventions: Drug: Proparacaine drops 0.05%; Drug: saline drops

• Registration Number: NCT00620997
• Lead Sponsor: London Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Status Verified: 2006-09
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Last Update Submitted: 2008-02-21
• Study First Posted: 2008-02-22
• Last Update Posted: 2008-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Proparacaine drops 0.05%	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
2	saline drops	placebo drops on a PRN basis for up to 7 days post injury Acetaminophen with Codeine for breakthrough pain Gatifloxacin drops

Primary Outcome Measures

Name	Time	Method
pain reduction	continuous

Secondary Outcome Measures

Name	Time	Method
delayed wound healing	days 3,5 ,7 postinjury
patient satisfaction	at 5 days post injury

Trial Locations

Locations (1)

London Health Sciences Center; 🇨🇦 London, Ontario, Canada