跳至主要内容
临床试验/NCT06212830
NCT06212830尚未招募早期 1 期

Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

This group will receive a combination of drugs including:

Targin, NSAIDS and Paracetamol.

干预措施: Targin (Drug)

Gabapentin

Active Comparator

This group will receive a combination of drugs including:

Gabapentin, NSAIDS and Paracetamol.

干预措施: Gabapentin (Drug)

Gabapentin

Active Comparator

This group will receive a combination of drugs including:

Gabapentin, NSAIDS and Paracetamol.

干预措施: NSAID (Drug)

Gabapentin

Active Comparator

This group will receive a combination of drugs including:

Gabapentin, NSAIDS and Paracetamol.

干预措施: Paracetamol (Drug)

Targin

Active Comparator

This group will receive a combination of drugs including:

Targin, NSAIDS and Paracetamol.

干预措施: NSAID (Drug)

Targin

Active Comparator

This group will receive a combination of drugs including:

Targin, NSAIDS and Paracetamol.

干预措施: Paracetamol (Drug)

Control

Active Comparator

This group will receive a combination of drugs including:

NSAIDS and Paracetamol.

干预措施: NSAID (Drug)

Control

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Adi Einan-Lifshitz

Professor

Assaf-Harofeh Medical Center

研究点 (1)

Loading locations...

相似试验