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Pain Relief - Tramadol Versus Ibuprofen

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Royal Liverpool University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:
NCT00111046
First received: May 16, 2005
Last updated: November 9, 2005
Last verified: May 2005
History of Changes

May 16, 2005
November 9, 2005
February 2001
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Compare levels of pain
Same as current
Complete list of historical versions of study NCT00111046 on ClinicalTrials.gov Archive Site
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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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Choroidal Melanoma
  • Melanoma
  • Eye Neoplasms
  • Drug: Ibuprofen
  • Drug: Tramadol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
February 2004
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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
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Royal Liverpool University Hospital
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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