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Ketamine for Pain in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03896230
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65 years old).

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Ketamine Injectable Product Phase 4

Detailed Description:

A literature review was performed that searched for randomized clinical trials involving ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous infusions or intranasal routes of ketamine administration were not included. Thirteen randomized clinical trials were identified meeting this criteria. None of these trials directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and adverse events. Many of these trials concluded with the recommendation that further studies were needed to evaluate the optimal dosing of ketamine for acute pain and determine which populations are most ideal for its use. This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety.

This study will include the following procedures:

  • Patient consent, screening, and enrollment will be performed by the treating resident or attending who will remain blinded
  • Patient will be assigned a subject number
  • Treating resident or attending will notify the ED pharmacist that a patient has been enrolled in the trial
  • ED pharmacist will notify the IV room and place the study drug order
  • Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on the predetermined randomization list
  • Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL solution of dextrose 5% or sodium chloride 0.9%
  • ED pharmacist will promptly deliver the study drug to the ED
  • Baseline vital signs will be assessed prior to starting the study drug infusion
  • Study drug will be administered via IV infusion over 20 minutes
  • Treating resident or attending will reassess the patient at 15 minutes from the end of infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to 120 minutes or until discharge, whichever is sooner

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 arms each arm getting a different dose of ketamine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded study (only the pharmacist supervisor that has no other involvement with the study will know the dose)
Primary Purpose: Treatment
Official Title: Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Arm 1: 0.1 mg/kg ketamine
0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.

Active Comparator: Arm 1: 0.2 mg/kg ketamine
0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.

Active Comparator: Arm 1: 0.3 mg/kg ketamine
0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.




Primary Outcome Measures :
  1. Pain score [ Time Frame: 2 hours post infusion completion ]
    Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 hours post infusion completion ]
    Frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute pain (including acute on chronic pain)
  • Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale
  • Provider determines the patient requires intravenous ketamine for analgesia

Exclusion Criteria:

  • History of hypersensitivity to ketamine
  • Altered mental status
  • Psychiatric illness
  • Known history of renal or hepatic insufficiency
  • Acute head or eye injury
  • Suspected intracranial hypertension or mass
  • Headache as the chief complaint
  • Alcohol or drug abuse
  • Received an analgesic within the last four hours
  • History of congestive heart failure
  • History of aortic or brain aneurysm
  • Active Chest Pain
  • Porphyria
  • Active methadone treatment
  • Pregnant or breastfeeding
  • Signs of respiratory, hemodynamic, or neurologic compromise

    • Systolic blood pressure < 90 mmHg or > 180 mmHg
    • Heart rate < 50 beats per minute or > 150 beats per minute
    • Respiratory rate < 10 breaths per minute or > 30 breaths per minute
    • Glasgow Coma Score < 15
  • Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896230


Contacts
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Contact: Gabrielle Procopio, PharmD 5519964368 Gabrielle.Procopio@hackensackmeridian.org
Contact: David Zodda, MD 5519963636 David.Zodda@hackensackmeridian.org

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gabrielle Procopio, PharmD         
Principal Investigator: Gabrielle Procopio, PharmD         
Sponsors and Collaborators
Hackensack Meridian Health

Publications:
2. American College of Emergency Physicians Policy Statement. Optimizing the treatment of acute pain in the emergency department. Ann Emerg Med. 2017;70:446-8.
4. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Highlights of the 2011 Drug Abuse Warning Network (DAWN) findings on drug-related emergency department visits. 2013. Rockville, MD.
12. American College of Emergency Physicians. "Sub-Dissociative Ketamine for Analgesia". Policy Resource and Education Paper. November 2017.
24. Ketalar [package insert]. Chestnut Ridge, NY. Par Pharmaceutical.
25. Food and Drug Administration (FDA). Extended-release (ER) and long-acting (LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm311290.pdf. Accessed September 20th, 2018.

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03896230     History of Changes
Other Study ID Numbers: Pro2018-0970
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All study related materials will be kept confidential as required by law. Written documentation and computer files will remain in a locked or password protected location, with access given to those directly responsible for the conduct of the study. In addition, all information will be recorded in such a manner that subjects whose data is included in the analysis cannot be identified directly or through identifiers linked to the subjects.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hackensack Meridian Health:
moderate to severe pain
emergency department patient
ketamine
Additional relevant MeSH terms:
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Ketamine
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action