NCT00825370

Protocolized vs Discretionary Use of Opioids in Acute Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone	1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
DRUG	IV opioid	Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-01-21
• Last updated: 2018-06-12
• Results posted: 2018-04-19

Locations

1 site across 1 country: United States