Clinical trial NCT02306759: Ketamine For Acute Treatment of Pain in Emergency Department
Official title: Ketamine For Acute Treatment of Pain in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: analgesia
ketamine
pain
Lead sponsor: The Brooklyn Hospital Center
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
timeFrame: 15 minutes after administration of study intervention
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: during the study period
measure: Patient Satisfaction of Pain Control Based on a Likert Scale
timeFrame: At the end of study period
measure: Mean Consumption of Rescue Analgesia
timeFrame: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)
measure: ED Length of Stay (Minutes)
timeFrame: throughout study completion
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: The Brooklyn Hospital Center
state: New York
Study officials:
affiliation: The Brooklyn Hospital Center
name: Billy Sin, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galinski M, Dolveck F, Combes X, Limoges V, Smail N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. doi: 10.1016/j.ajem.2006.11.016.
citation: Gurnani A, Sharma PK, Rautela RS, Bhattacharya A. Analgesia for acute musculoskeletal trauma: low-dose subcutaneous infusion of ketamine. Anaesth Intensive Care. 1996 Feb;24(1):32-6. doi: 10.1177/0310057X9602400106.
citation: Yeaman F, Oakley E, Meek R, Graudins A. Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study. Emerg Med Australas. 2013 Apr;25(2):161-7. doi: 10.1111/1742-6723.12059. Epub 2013 Mar 20.
citation: Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8.
citation: Ahern TL, Herring AA, Stone MB, Frazee BW. Effective analgesia with low-dose ketamine and reduced dose hydromorphone in ED patients with severe pain. Am J Emerg Med. 2013 May;31(5):847-51. doi: 10.1016/j.ajem.2013.02.008. Epub 2013 Apr 18.
citation: Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.