Pain Relief - Tramadol Versus Ibuprofen

Phase 1

• Conditions: Choroidal Melanoma; Melanoma; Eye Neoplasms

• Registration Number: NCT00111046
• Lead Sponsor: Royal Liverpool University Hospital

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 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.

Study Timeline

• Study Start: 2001-02
• Study Completion: 2004-02
• Status Verified: 2005-05
• Study First Submitted: 2005-05-16
• Study First Submitted QC: 2005-05-16
• Study First Posted: 2005-05-17
• Last Update Submitted: 2005-11-09
• Last Update Posted: 2005-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare levels of pain

Trial Locations

Locations (1)

Royal Liverpool University Hospital; 🇬🇧 Liverpool, Merseyside, United Kingdom