Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299039
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2006-03-02
Brief Title:
T3AI-Pain After Breast Surgery
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol 3 for the Treatment of Pain After Breast Surgery
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
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:
T3AI
Brief Summary:
Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol 3 300 mg acetaminophen 30 mg codeine 15 mg caffeine per tablet We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol 3 in patients undergoing outpatient breast surgery
Detailed Description:
Block randomization will be used to randomize patients to one of two combinations Group A will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen Group B will receive capsules containing 600 mg Acetaminophen 15 mg caffeine and 60 mg codeine Capsules are placed in identical dossettes containing a seven day supply Patients are instructed to start taking their medications post-op and continue until they are pain free All participants are given a series of blank Visual Analogue scales and Likert scales and instructed to record their level of pain intensity and pain relief four times per day for the entire week Peri-operative pain management will be standardized Patients will not receive pre-operative analgesics Intra-operative analgesia will be intravenous opioids as selected by anaesthesiology No localregional anaesthesia will be used Intravenous ketorolac will not be allowed for trial participants All patients will receive intravenous opioid and anti-emetic if required in PACU Any patients with peri-operative complications or other problems requiring admission or alternative analgesics will be excluded
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