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临床试验/NCT00111046
NCT00111046Unknown1 期

Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study

Royal Liverpool University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年2月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
入组人数
40
试验地点
2
主要终点
Compare levels of pain

研究概览

简要总结

The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.

详细描述

Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.

This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.

As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.

Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.

Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.

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
Single

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

  • All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
  • They should be adults who are of a sound frame of mind to give an informed consent to participate.

排除标准

  • Patients less than 18 years of age
  • Patients of unsound mind not capable of giving informed consent
  • Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.

结局指标

主要结局

Compare levels of pain

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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