NCT00111046

Pain Relief - Tramadol Versus Ibuprofen

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Royal Liverpool University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Choroidal Melanoma
• Melanoma
• Eye Neoplasms

Interventions

Type	Name	Description
DRUG	Ibuprofen
DRUG	Tramadol

Timeline

• Start date: 2001-02-01
• Completion: 2004-02-01
• First posted: 2005-05-17
• Last updated: 2005-11-10

Locations

1 site across 1 country: United Kingdom