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Sponsored by: |
London Health Sciences Centre |
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Information provided by: | London Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00620997 |
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 | Intervention | Phase |
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Corneal Abrasions |
Drug: Proparacaine drops 0.05% Drug: saline drops |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries |
Enrollment: | 43 |
Study Start Date: | October 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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
|
2: Placebo Comparator
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
London Health Sciences Center | |
London, Ontario, Canada, N6A 5W9 |
Principal Investigator: | Scott B Anderson, MD FRCPC | London Health Sciences Center |
Responsible Party: | London Health Sciences Centre ( Dr. Scott Anderson ) |
Study ID Numbers: | London HSC |
Study First Received: | February 12, 2008 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00620997 |
Health Authority: | Canada: Ethics Review Committee |
cornea analgesia topical anesthetic |
Corneal Diseases Emergencies Proxymetacaine |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |