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Pain Relief - Tramadol Versus Ibuprofen

NCT ID: NCT00111046

Last Updated: 2005-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Choroidal Melanoma Melanoma Eye Neoplasms

Keywords

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Pain Relief Choroidal melanoma plaque radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Ibuprofen

Intervention Type DRUG

Tramadol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Liverpool University Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Bertil Damato

Role: PRINCIPAL_INVESTIGATOR

Royal Liverpool University Hospital

Locations

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Royal Liverpool University Hospital

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R&D 1931

Identifier Type: -

Identifier Source: secondary_id

2K/261

Identifier Type: -

Identifier Source: org_study_id