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Sponsored by: |
Royal Liverpool University Hospital |
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Information provided by: | Royal Liverpool University Hospital |
ClinicalTrials.gov Identifier: | NCT00111046 |
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 | Intervention | Phase |
---|---|---|
Choroidal Melanoma Melanoma Eye Neoplasms |
Drug: Ibuprofen Drug: Tramadol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study |
Estimated Enrollment: | 40 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | February 2004 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Merseyside | |
Royal Liverpool University Hospital | |
Liverpool, Merseyside, United Kingdom, L8 0RU |
Principal Investigator: | Bertil Damato | Royal Liverpool University Hospital |
Study ID Numbers: | 2K/261, R&D 1931 |
Study First Received: | May 16, 2005 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00111046 |
Health Authority: | United Kingdom: National Health Service |
Pain Relief Choroidal melanoma plaque radiotherapy |
Ibuprofen Eye Neoplasms Tramadol Eye Diseases Pain Melanoma Neuroendocrine Tumors |
Melanoma of the choroid Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Pain, Postoperative |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Depressants Narcotics Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Nevi and Melanomas Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |