Viewing Study NCT00111046



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00111046
Status: UNKNOWN
Last Update Posted: 2005-11-10
First Post: 2005-05-16

Brief Title: Pain Relief - Tramadol Versus Ibuprofen
Sponsor: Royal Liverpool University Hospital
Organization: Royal Liverpool University Hospital

Study Overview

Official Title: Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma Randomised Control Trial of Tramadol Vs Ibuprofen A Pilot Study
Status: UNKNOWN
Status Verified Date: 2005-05
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
RD 1931 None None None