Pain Relief - Tramadol Versus Ibuprofen
Primary Purpose
Choroidal Melanoma, Melanoma, Eye Neoplasms
Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Ibuprofen
Tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Melanoma focused on measuring Pain Relief, Choroidal melanoma, plaque radiotherapy
Eligibility Criteria
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.
Sites / Locations
- Royal Liverpool University Hospital
Outcomes
Primary Outcome Measures
Compare levels of pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00111046
First Posted
May 16, 2005
Last Updated
November 9, 2005
Sponsor
Royal Liverpool University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00111046
Brief Title
Pain Relief - Tramadol Versus Ibuprofen
Official Title
Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Liverpool University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma, Melanoma, Eye Neoplasms
Keywords
Pain Relief, Choroidal melanoma, plaque radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Tramadol
Primary Outcome Measure Information:
Title
Compare levels of pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertil Damato
Organizational Affiliation
Royal Liverpool University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L8 0RU
Country
United Kingdom
12. IPD Sharing Statement
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Pain Relief - Tramadol Versus Ibuprofen
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