CompletedPhase 1ketamine

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

NCT ID

NCT01740492

Target Enrollment

75 participants

Start Date

2012-09

Est. Completion

2014-06

About This Study

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.

Conditions Studied

Pain

Interventions

•Ketamine 0.15mg/kg
•Ketamine 0.3mg/kg
•Placebo

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

* English speaking
* Adults age 18-65
* Able to understand and give informed consent
* Comfortable with the experimental protocol as outlined to them by the research team
* Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
* Acute pain, pain duration \< 7days
* Deemed by treating ED attending physician to require IV opioid analgesia
* ASA (American Society of Anesthesiologists) class I or II

Exclusion Criteria:

* Previously enrolled in the study
* Neurologic, respiratory, or hemodynamic compromise
* GCS (Glasgow Coma Scale) \<15
* Pox \<94%, RR \<10, or RR \>22
* SBP \<90, SBP\>180, or DBP \>110
* Discretion of treating physician
* Pregnancy or breastfeeding
* Known or suspected allergy to ketamine or morphine
* Ketamine within 24 hours of presentation (prescription or illicit drugs)
* Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes)
* Known Renal (Cr\>2.0) or Liver Failure
* Unstable psychiatric disease (as per treating physician)
* History of stroke
* History of cardiac disease
* Prior myocardial infarction; Angina (Stable or Unstable)
* Cardiac stents or bypass surgery

Study Locations (1)

Rhode Island Hospital

Providence, Rhode Island, United States