NCT00910208

Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.

Detailed description

The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms: 1. PCA with 1.0 mg morphine demand dosing every 6 minutes, 2. PCA with 1.5 mg demand dosing every 6 minutes and 3. a non-PCA comparison group. All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider. We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Patient-controlled analgesia	Intravenous morphine delivered via Curlin painsmart PCA device
DRUG	morphine	Intravenous morphine

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-05-29
• Last updated: 2019-12-27
• Results posted: 2019-12-27

Locations

1 site across 1 country: United States