Pain Relief - Tramadol Versus Ibuprofen
Information source: Royal Liverpool University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choroidal Melanoma; Melanoma; Eye Neoplasms
Intervention: Ibuprofen (Drug); Tramadol (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Royal Liverpool University Hospital Official(s) and/or principal investigator(s):
Bertil Damato, Principal Investigator, Affiliation: Royal Liverpool University Hospital
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Compare levels of pain
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Royal Liverpool University Hospital, Liverpool, Merseyside L8 0RU, United Kingdom
Additional Information
Starting date: February 2001
Ending date: February 2004
Last updated: November 9, 2005
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