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临床试验/NCT00620997
NCT00620997已完成1 期

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

London Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
43
试验地点
1
主要终点
pain reduction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Proparacaine drops 0.05% (Drug)

2

Placebo Comparator

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

Acetaminophen with Codeine for breakthrough pain

Gatifloxacin drops

干预措施: saline drops (Drug)

结局指标

主要结局

pain reduction

时间窗: continuous

次要结局

  • patient satisfaction(at 5 days post injury)
  • delayed wound healing(days 3,5 ,7 postinjury)

研究者

申办方类型
Other

研究点 (1)

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