|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 16, 2005 | ||||
| Last Updated Date | November 9, 2005 | ||||
| Start Date ICMJE | February 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Compare levels of pain | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00111046 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pain Relief - Tramadol Versus Ibuprofen | ||||
| Official Title ICMJE | 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 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 Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00111046 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2K/261, R&D 1931 | ||||
| Study Sponsor ICMJE | Royal Liverpool University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Royal Liverpool University Hospital | ||||
| Verification Date | May 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||