Proparacaine vs Placebo for Corneal Injuries

Corneal Abrasions Clinical Trial

— Dogma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620997
• Other study ID #: London HSC
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2008
• Last updated: February 21, 2008
• Start date: October 2005
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Abrasions

Intervention

Drug:
• Proparacaine drops 0.05%
topical, 0.05% drops, PRN continuously for up to 7 days
• saline drops
saline drops continuously PRN for up to 7 days

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain reduction		continuous	No
Secondary	patient satisfaction		at 5 days post injury	No
Secondary	delayed wound healing		days 3,5 ,7 postinjury	Yes