Ketamine For Acute Treatment of Pain in Emergency Department

Pain Clinical Trial

— KETAFAP  

Official title:

Ketamine For Acute Treatment of Pain in Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306759
• Other study ID #: 669443-1
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2014
• Last updated: November 13, 2015
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: The Brooklyn Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketamine
Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
• Placebo
Normal saline 50ml, administered over 15 minutes

Locations

Country	Name	City	State
United States	The Brooklyn Hospital Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Brooklyn Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

Galinski M, Dolveck F, Combes X, Limoges V, Smaïl 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Pain as described by VAS		at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes	No
Secondary	Incidence of adverse events		at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes	Yes
Secondary	Patient satisfaction of pain control based on a Likert Scale		at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes	No
Secondary	The number of patients who consumed an adjuvant pain medication for analgesia		at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes	No
Secondary	ED Length of stay		Total length of stay per patient	No