Clinical trial NCT01740492: Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Official title: Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Ketamine
Acute pain
Pain control
Pain
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
timeFrame: Between patient arrival and patient discharge
Secondary outcomes:
measure: Safety--Determine the incidence of adverse events associated with ketamine and morphine, versus morphine alone at 5 minutes, 30 minutes, and hourly up to 6 hours.
timeFrame: 15 minutes, 30 minutes, hourly up to 6 hours
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Francesca Beaudoin, MD
role: PRINCIPAL_INVESTIGATOR
References: