Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 10:48 PM
Study NCT ID:
NCT01311895
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2011-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone
Status:
COMPLETED
Status Verified Date:
2018-04
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:
The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: