Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474721
Status:
COMPLETED
Last Update Posted:
2007-05-17
First Post:
2007-05-16
Brief Title:
Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
Status:
COMPLETED
Status Verified Date:
2007-05
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:
None
Brief Summary:
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs
Detailed Description:
We conducted a randomized double-blinded equivalence trial Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine 1 mgkg as codeine or ibuprofen 10 mgkg They provided Color Analog Scale pain scores at baseline and at 20 40 and 60 minutes after medication administration The primary outcome measured was the difference in changes in pain score at 40 minutes compared against a previously described minimal clinically significant change in pain score of 2 cm Additional outcomes included need for rescue medication and adverse effects
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