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Ketamine For Acute Treatment of Pain in Emergency Department (KETAFAP)

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
The Brooklyn Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring analgesia, ketamine, pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Brooklyn Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Adverse Events
Incidence or number of participants with adverse events.
Patient Satisfaction of Pain Control Based on a Likert Scale
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
ED Length of Stay (Minutes)
ED Length of stay (minutes) throughout study period

Full Information

First Posted
November 25, 2014
Last Updated
July 11, 2017
Sponsor
The Brooklyn Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT02306759
Brief Title
Ketamine For Acute Treatment of Pain in Emergency Department
Acronym
KETAFAP
Official Title
Ketamine For Acute Treatment of Pain in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Brooklyn Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
analgesia, ketamine, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline 50ml, administered over 15 minutes
Primary Outcome Measure Information:
Title
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
Description
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.
Time Frame
15 minutes after administration of study intervention
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Incidence or number of participants with adverse events.
Time Frame
during the study period
Title
Patient Satisfaction of Pain Control Based on a Likert Scale
Description
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.
Time Frame
At the end of study period
Title
Mean Consumption of Rescue Analgesia
Time Frame
at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)
Title
ED Length of Stay (Minutes)
Description
ED Length of stay (minutes) throughout study period
Time Frame
throughout study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billy Sin, Pharm.D.
Organizational Affiliation
The Brooklyn Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17499654
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.
Results Reference
background
PubMed Identifier
8669651
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.
Results Reference
background
PubMed Identifier
23560967
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.
Results Reference
background
PubMed Identifier
24712757
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.
Results Reference
background
PubMed Identifier
23602757
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.
Results Reference
background
PubMed Identifier
24127709
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.
Results Reference
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Ketamine For Acute Treatment of Pain in Emergency Department

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