Ketamine For Acute Treatment of Pain in Emergency Department

NCT02306759 | Completed Phase 4 Results

• 1 other identifier: 669443-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

analgesia; ketamine; pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes

  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.

  15 minutes after administration of study intervention

Secondary Outcomes (4)

• Number of Participants With Adverse Events

  during the study period

• Patient Satisfaction of Pain Control Based on a Likert Scale

  At the end of study period

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ketamine DRUG

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

Treatment

Placebo DRUG

Normal saline 50ml, administered over 15 minutes

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Brooklyn Hospital Center: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Related Publications (6)

• 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.

  PMID: 17499654 BACKGROUND

• 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.

  PMID: 8669651 BACKGROUND

• 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.

  PMID: 23560967 BACKGROUND

• 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.

  PMID: 24712757 BACKGROUND

• 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.

  PMID: 23602757 BACKGROUND

• 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.

  PMID: 24127709 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director, Emergency Medicine Clinical Research Program
• Organization: The Brooklyn Hospital Center

bsin@tbh.org

718-250-6250

Study Officials

• Billy Sin, Pharm.D.

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Clinical Pharmacy Educator

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 3, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 9, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)