Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pain questionnaires
研究概览
简要总结
Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery.
Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient.
In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above the age of 15 years
- •Patients who are undergoing CXL treatment
排除标准
- •Renal and/or hepatic failure
- •Patients under the age of 15
研究组 & 干预措施
Targin
This group will receive a combination of drugs including:
Targin, NSAIDS and Paracetamol.
干预措施: Targin (Drug)
Gabapentin
This group will receive a combination of drugs including:
Gabapentin, NSAIDS and Paracetamol.
干预措施: Gabapentin (Drug)
Gabapentin
This group will receive a combination of drugs including:
Gabapentin, NSAIDS and Paracetamol.
干预措施: NSAID (Drug)
Gabapentin
This group will receive a combination of drugs including:
Gabapentin, NSAIDS and Paracetamol.
干预措施: Paracetamol (Drug)
Targin
This group will receive a combination of drugs including:
Targin, NSAIDS and Paracetamol.
干预措施: NSAID (Drug)
Targin
This group will receive a combination of drugs including:
Targin, NSAIDS and Paracetamol.
干预措施: Paracetamol (Drug)
Control
This group will receive a combination of drugs including:
NSAIDS and Paracetamol.
干预措施: NSAID (Drug)
Control
This group will receive a combination of drugs including:
NSAIDS and Paracetamol.
干预措施: Paracetamol (Drug)
结局指标
主要结局
Pain questionnaires
时间窗: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
次要结局
未报告次要终点
研究者
Adi Einan-Lifshitz
Professor
Assaf-Harofeh Medical Center
