Pain Relief - Tramadol Versus Ibuprofen

Melanoma Clinical Trial

Official title:

Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00111046
• Other study ID #: 2K/261
• Secondary ID: R&D 1931
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 16, 2005
• Last updated: November 9, 2005
• Start date: February 2001
• Est. completion date: February 2004

Study information

• Verified date: May 2005
• Source: Royal Liverpool University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Melanoma
• Eye Neoplasms
• Melanoma

Intervention

Drug:
• Ibuprofen

• Tramadol

Locations

Country	Name	City	State
United Kingdom	Royal Liverpool University Hospital	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Royal Liverpool University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare levels of pain