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Pain Relief - Tramadol Versus Ibuprofen
This study is ongoing, but not recruiting participants.
Study NCT00111046   Information provided by Royal Liverpool University Hospital
First Received: May 16, 2005   Last Updated: November 9, 2005   History of Changes

May 16, 2005
November 9, 2005
February 2001
 
Compare levels of pain
Same as current
Complete list of historical versions of study NCT00111046 on ClinicalTrials.gov Archive Site
 
 
 
Pain Relief - Tramadol Versus Ibuprofen
Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study

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.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
  • Choroidal Melanoma
  • Melanoma
  • Eye Neoplasms
  • Drug: Ibuprofen
  • Drug: Tramadol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
February 2004
 

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00111046
 
2K/261, R&D 1931
Royal Liverpool University Hospital
 
Principal Investigator: Bertil Damato Royal Liverpool University Hospital
Royal Liverpool University Hospital
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP