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Phase 4 N=60 Randomized Quadruple-blind Treatment

Ketamine For Acute Treatment of Pain in Emergency Department

Pain

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes — 3.5; 6.0 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ketamine (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Brooklyn Hospital Center
Primary completion
Nov 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
3.5; 6.0
SECONDARY
Number of Participants With Adverse Events
2; 4
SECONDARY
Patient Satisfaction of Pain Control Based on a Likert Scale
8.57; 6.05
SECONDARY
Mean Consumption of Rescue Analgesia
0; 0; 0.23; 0.14; 0.37; 0.28
SECONDARY
ED Length of Stay (Minutes)
267; 292

Summary

The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department. The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years old and older presenting with acute generalized pain
  • Describes pain to be greater than or equal to 3 on the Visual Analogue Scale (VAS)
  • Provides informed consent

Exclusion Criteria

  • Patients who are admitted to the hospital
  • Severe hypertension(≥180/100)
  • Presence of or suspected for traumatic head injury with or without loss of consciousness
  • Presence of or suspected for myocardial ischemia
  • Presence of or suspected alcohol intoxication
  • Hemodynamic instability
  • History of schizophrenia
  • History of Sickle cell crisis / presenting with acute sickle cell crisis
  • History of or suspected recreational substance abuse
  • History of or suspected diagnosis of headache or migraine
  • History of or suspected diagnosis increase in intracranial/intraocular pressure
  • Known or suspected pregnancy
  • Allergy to ketamine or morphine
  • Administration of opioids in previous 4 hours
  • Patients with language barriers or in altered mental status who are unable to describe pain
  • Patients weighing over 166kg
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02306759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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