Ketamine For Acute Treatment of Pain in Emergency Department

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes

Placebo

Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline 50ml, administered over 15 minutes

Interventions

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Ketamine

Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes

Intervention Type DRUG

Placebo

Normal saline 50ml, administered over 15 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No