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Pain Relief - Tramadol Versus Ibuprofen

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ClinicalTrials.gov Identifier: NCT00111046
Recruitment Status : Unknown
Verified May 2005 by Royal Liverpool University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2005
Last Update Posted : November 10, 2005
Sponsor:
Information provided by:
Royal Liverpool University Hospital

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.

Condition or disease Intervention/treatment Phase
Choroidal Melanoma Melanoma Eye Neoplasms Drug: Ibuprofen Drug: Tramadol Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : February 2001
Study Completion Date : February 2004





Primary Outcome Measures :
  1. Compare levels of pain


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111046


Locations
United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L8 0RU
Sponsors and Collaborators
Royal Liverpool University Hospital
Investigators
Principal Investigator: Bertil Damato Royal Liverpool University Hospital

ClinicalTrials.gov Identifier: NCT00111046     History of Changes
Other Study ID Numbers: 2K/261
R&D 1931
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: November 10, 2005
Last Verified: May 2005

Keywords provided by Royal Liverpool University Hospital:
Pain Relief
Choroidal melanoma
plaque radiotherapy

Additional relevant MeSH terms:
Melanoma
Eye Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Eye Diseases
Ibuprofen
Tramadol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants