Proparacaine vs Placebo for Corneal Injuries

NCT00620997 | Completed Phase 1

• 1 other identifier: London HSC
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Abrasions

Keywords

cornea; analgesia; topical; anesthetic

Outcome Measures

Primary Outcomes (1)

• pain reduction

  continuous

Secondary Outcomes (2)

• patient satisfaction

  at 5 days post injury

• delayed wound healing

  days 3,5 ,7 postinjury

Study Arms (2)

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%

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

Interventions

Proparacaine drops 0.05% DRUG

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

1

saline drops DRUG

saline drops continuously PRN for up to 7 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with acute (within 24 hrs) traumatic corneal injuries

You may not qualify if:

• immunocompromised
• known allergy to local anesthetic
• unable to consent /follow instructions for dosing / go to follow-up appointments
• previous ocular pathology

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Algarni AM, Guyatt GH, Turner A, Alamri S. Antibiotic prophylaxis for corneal abrasion. Cochrane Database Syst Rev. 2022 May 27;5(5):CD014617. doi: 10.1002/14651858.CD014617.pub2.

  PMID: 35622535 DERIVED

MeSH Terms

Conditions

Corneal Injuries; Corneal Diseases; Agnosia

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott B Anderson, MD FRCPC

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: October 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 22, 2008

Record last verified: 2006-09

Locations

CA (1)