Proparacaine vs Placebo for Corneal Injuries (Dogma)

• ClinicalTrials.gov Identifier: NCT00620997
• Recruitment Status: Completed
• First Posted: February 22, 2008
• Last Update Posted: February 22, 2008
• Sponsor: London Health Sciences Centre
• Information provided by: London Health Sciences Centre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Corneal Abrasions	Drug: Proparacaine drops 0.05%; Drug: saline drops	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries
• Study Start Date: October 2005
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: September 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Proparacaine drops 0.05%; topical, 0.05% drops, PRN continuously for up to 7 days
Placebo Comparator: 2; placebo drops on a PRN basis for up to 7 days post injury Acetaminophen with Codeine for breakthrough pain Gatifloxacin drops	Drug: saline drops; saline drops continuously PRN for up to 7 days

Outcome Measures

Primary Outcome Measures :

1. pain reduction [ Time Frame: continuous ]

Secondary Outcome Measures :

1. patient satisfaction [ Time Frame: at 5 days post injury ]
2. delayed wound healing [ Time Frame: days 3,5 ,7 postinjury ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

London Health Sciences Center

London, Ontario, Canada, N6A 5W9

Sponsors and Collaborators

London Health Sciences Centre

Investigators

• Principal Investigator: Scott B Anderson, MD FRCPC; London Health Sciences Center

More Information

• Responsible Party: Dr. Scott Anderson, London Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT00620997
• Other Study ID Numbers: London HSC
• First Posted: February 22, 2008
• Last Update Posted: February 22, 2008
• Last Verified: September 2006

Keywords provided by London Health Sciences Centre:

cornea; analgesia; topical; anesthetic

Additional relevant MeSH terms:

Corneal Injuries; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries; Proxymetacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents