Proparacaine vs Placebo for Corneal Injuries (Dogma)

This study has been completed.
Sponsor:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00620997
First received: February 12, 2008
Last updated: February 21, 2008
Last verified: September 2006

February 12, 2008
February 21, 2008
October 2005
September 2006   (final data collection date for primary outcome measure)
pain reduction [ Time Frame: continuous ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00620997 on ClinicalTrials.gov Archive Site
  • patient satisfaction [ Time Frame: at 5 days post injury ] [ Designated as safety issue: No ]
  • delayed wound healing [ Time Frame: days 3,5 ,7 postinjury ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Proparacaine vs Placebo for Corneal Injuries
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Corneal Abrasions
  • Drug: Proparacaine drops 0.05%
    topical, 0.05% drops, PRN continuously for up to 7 days
  • Drug: saline drops
    saline drops continuously PRN for up to 7 days
  • 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

    Intervention: Drug: Proparacaine drops 0.05%
  • Placebo Comparator: 2

    placebo drops on a PRN basis for up to 7 days post injury

    Acetaminophen with Codeine for breakthrough pain

    Gatifloxacin drops

    Intervention: Drug: saline drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00620997
London HSC
No
Dr. Scott Anderson, London Health Sciences Centre
London Health Sciences Centre
Not Provided
Principal Investigator: Scott B Anderson, MD FRCPC London Health Sciences Center
London Health Sciences Centre
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP