Corneal Abrasions Clinical Trial
Official title:
Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01753583 -
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
|
N/A |