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

Study Description

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

MedlinePlus related topics: Melanoma

Drug Information available for: Ibuprofen Tramadol Ibuprofen sodium Ibuprofen lysine Midol

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Compare levels of pain

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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.

Contacts and Locations

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

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United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L8 0RU

Sponsors and Collaborators

Royal Liverpool University Hospital

Investigators

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Principal Investigator:	Bertil Damato	Royal Liverpool University Hospital

More Information

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ClinicalTrials.gov Identifier:	NCT00111046
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:

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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

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