Pain Relief - Tramadol Versus Ibuprofen
Recruitment status was Active, not recruiting
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study |
- Compare levels of pain
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.
Contacts and Locations| United Kingdom | |
| Royal Liverpool University Hospital | |
| Liverpool, Merseyside, United Kingdom, L8 0RU | |
| Principal Investigator: | Bertil Damato | Royal Liverpool University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00111046 History of Changes |
| Other Study ID Numbers: | 2K/261, R&D 1931 |
| Study First Received: | May 16, 2005 |
| Last Updated: | November 9, 2005 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Royal Liverpool University Hospital:
|
Pain Relief Choroidal melanoma plaque radiotherapy |
Additional relevant MeSH terms:
|
Neoplasms Eye Neoplasms Melanoma Neoplasms by Site Eye Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Ibuprofen Tramadol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 17, 2013