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.

Condition	Treatment or Intervention	Phase
Choroidal melanoma Melanoma Eye Neoplasms	Drug: Ibuprofen  Drug: Tramadol	Phase I Phase II

Further Study Details: 

Primary Outcomes: Compare levels of pain
Expected Total Enrollment:  40

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

United Kingdom, Merseyside
      Royal Liverpool University Hospital, Liverpool,  Merseyside,  L8 0RU,  United Kingdom

Study ID Numbers:  2K/261; R&D 1931
Record last reviewed:  May 2005
Last Updated:  May 16, 2005
Record first received:  May 16, 2005
ClinicalTrials.gov Identifier:  NCT00111046
Health Authority: United Kingdom: National Health Service (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17