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Completed

NCT Number: NCT00620997

Proparacaine vs Placebo for 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proparacaine drops 0.05%

Drug

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

saline drops

Drug

saline drops continuously PRN for up to 7 days

Primary outcomes

  1. pain reduction

    Time frame: continuous

Secondary outcomes

  1. patient satisfaction

    Time frame: at 5 days post injury

  2. delayed wound healing

    Time frame: days 3,5 ,7 postinjury

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: Dogma

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 22, 2008
Registry last updated
Feb 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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