Ketamine For Acute Treatment of Pain in Emergency Department

Phase 4

Completed

Conditions: Pain

Interventions: Drug: Placebo
Drug: Ketamine

Registration Number: NCT02306759

Lead Sponsor: The Brooklyn Hospital Center

Brief 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.

Detailed Description: 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 is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Treatment	Ketamine	Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes	15 minutes after administration of study intervention	Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	during the study period	Incidence or number of participants with adverse events.
Patient Satisfaction of Pain Control Based on a Likert Scale	At the end of study period	Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.
Mean Consumption of Rescue Analgesia	at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)
ED Length of Stay (Minutes)	throughout study completion	ED Length of stay (minutes) throughout study period