NCT01311895

Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	H2O	2 mg IV hydromorphone
DRUG	1+1	1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-03-10
• Last updated: 2018-05-18
• Results posted: 2018-05-18

Locations

1 site across 1 country: United States