Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
研究概览
简要总结
The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.
详细描述
This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.
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
- Double (Participant, Care Provider)
盲法说明
Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bromfenac 0.09%
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
干预措施: Use of bromfenac 0.09% to reduce intravitreal injection pain (Drug)
Artificial Tear
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
干预措施: Use of artificial tears to reduce intravitreal injection pain (Drug)
结局指标
主要结局
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
时间窗: Patients will be asked in the office for their pain rating 5 minutes after injection
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
时间窗: Patients will be called for their rating 24 hours after injection
from 0 through 10, in which 10 is the worst pain level.
Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
时间窗: Patients will be called for their rating 6 hours after injection
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
时间窗: Patients will be called for their rating 24 hours after injection
Patients will be asked to report their pain on the Short Form McGill Pain Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
次要结局
未报告次要终点
研究者
Sunir Garg MD
Retina Physician and Surgeon, Co-Director of Retina Research
Wills Eye