NCT00627367

Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain

A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone	Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
DRUG	Nonprotocolized	An IV opioid the type and dose of which will be determined by the treating clinician

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-03-03
• Last updated: 2018-04-05
• Results posted: 2018-04-05

Locations

1 site across 1 country: United States