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Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Choroidal Melanoma, Melanoma, Eye Neoplasms

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Trial Information

Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Compare levels of pain

Principal Investigator

Bertil Damato

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Liverpool University Hospital

Authority:

United Kingdom: National Health Service

Study ID:

2K/261

NCT ID:

NCT00111046

Start Date:

February 2001

Completion Date:

February 2004

Related Keywords:

  • Choroidal Melanoma
  • Melanoma
  • Eye Neoplasms
  • Pain Relief
  • Choroidal melanoma
  • plaque radiotherapy
  • Neoplasms
  • Eye Neoplasms
  • Melanoma

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