NCT01740492

Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to address both the management and evaluation of pain. The primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. Another aim is to examine the safety of low dose ketamine compared to opioids alone. The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

Detailed description

Management and assessment of pain in the Emergency Department (ED) can be challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, inadequate analgesia is often a problem when opioids alone are relied on for pain control. In the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. Ketamine may play a role in maximizing analgesia in the ED.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ketamine 0.15mg/kg	0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
DRUG	Ketamine 0.3mg/kg	0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
OTHER	Placebo	Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-12-04
• Last updated: 2022-09-07

Locations

1 site across 1 country: United States