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
  Purpose

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 Intervention Phase
Choroidal Melanoma
Melanoma
Eye Neoplasms
Drug: Ibuprofen
Drug: Tramadol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Royal Liverpool University Hospital:

Primary Outcome Measures:
  • Compare levels of pain

Estimated Enrollment: 40
Study Start Date: February 2001
Estimated Study Completion Date: February 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00111046     History of Changes
Other Study ID Numbers: 2K/261, R&D 1931
Study First Received: May 16, 2005
Last Updated: November 9, 2005
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on October 20, 2014