Clinical Trial: Pain Relief - Tramadol Versus Ibuprofen
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Royal Liverpool University Hospital
Current Primary Outcome: Compare levels of pain
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Royal Liverpool University Hospital
Dates:
Date Received: May 16, 2005
Date Started: February 2001
Date Completion: February 2004
Last Updated: November 9, 2005
Last Verified: May 2005
