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Ketamine: Comparison of IV Push vs. IV Drip

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ClinicalTrials.gov Identifier: NCT02363270
Recruitment Status : Completed
First Posted : February 13, 2015
Results First Posted : October 2, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 13, 2015
Results First Submitted Date  ICMJE March 18, 2017
Results First Posted Date  ICMJE October 2, 2017
Last Update Posted Date November 22, 2017
Actual Study Start Date  ICMJE April 1, 2015
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
Overall Rate of Feeling Unreality [ Time Frame: 30 minutes ]
Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
Adverse effects [ Time Frame: 30 minutes ]
Quantification and comparison of adverse effects of sub-dissociative dose Ketamine given by intravenous push or infusion in the treatment of acute severe pain in patients of the ED.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
Pain Relief [ Time Frame: 30 minutes ]
Pain Relief at 30 minutes post administration of medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine: Comparison of IV Push vs. IV Drip
Official Title  ICMJE Comparison of Intravenous Push Dose of Low Dose Ketamine to Short Infusion of Low Dose Ketamine for Treatment of Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study
Brief Summary Our previous published research comparing the efficacy of intravenous ketamine to morphine has shown ketamine to provide equivalent relief of moderate to severe acute pain in emergency medicine patients. Secondary analysis of the previous published research has also revealed ketamine to have statistically more side effects. The investigators believe that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the side effects experienced by recipients of ketamine.
Detailed Description

Ketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist that blocks the release of excitatory neurotransmitter glutamate and provides anesthesia, amnesia and analgesia by virtue of decreasing central sensitization and "wind-up" phenomenon. At low (sub-dissociative, analgesics) doses of 0.1-0.4 mg/kg either as an adjunct to opioid analgesics or as a single agent, ketamine provides good analgesia while preserving airway patency, ventilation, and cardiovascular stability. In addition, the low-dose of ketamine increases the analgesic potency of opioids thus decreasing their requirements. Several recent studies of low-dose ketamine administered together with morphine provided acceptable pain relief to 55-60% of patients with minor side effects of dizziness, nausea and feeling of unreality. More recently the investigators conducted a research comparing Low-Dose Ketamine to Morphine for Moderate to Severe Pain in the Emergency Department with respect its analgesic efficacy and safety. Results demonstrated similar pain relief at 30 min between 2 groups. However, 70% of patients in ketamine group had minor side effects at 5 min and 35% of patients at 30 min, as compared to 51% at 5 min. and 31% at 15 min. in the morphine group. The most common side effects reported by ketamine patients were dizziness, nausea, feeling of unreality, and mood changes.

Based on the above mentioned data from our previous published research study, we hypothesized that low-dose ketamine given as a short infusion over 15 min will provide similar analgesic efficacy as an intravenous push-dose but with much less side effects. There are several research papers that support our hypothesis.

A prospective, randomized trial compared two analgesic regimens, morphine with ketamine (K group) or morphine with placebo (P group) for severe acute pain in 73 trauma patients with a visual analog scale (VAS) score of at least 60/100. Morphine was administered at 0.1mg/kg and patients in the K group received 0.2 mg/kg of intravenous ketamine over 10 minutes, and the patients in the P group received isotonic sodium chloride solution. The results showed comparable change in VAS score at 30 minutes (34 mm (K) vs. 39 mm (P)) but reduced morphine consumption in the ketamine group (0.14 mg/kg (K) vs 0.2 mg/kg (P)).

A double-blind trial of 40 adult patients with acute musculoskeletal trauma compared a low-dose ketamine by subcutaneous infusion (0.1 mg/kg/h) with intermittent morphine (0.1 mg/kg IV every 4 hours ) and demonstrated better pain relief, less sedation and less nausea and vomiting with ketamine infusion than with intermittent morphine. In addition, none of the patients in ketamine group required supplementary analgesia.

A prospective case series of 20 unselected adult ED patients with acute pain that evaluated analgesic feasibility of low-dose ketamine infusion was conducted in an urban public hospital over a course of 5 months. Patients received 15mg of intravenous push dose ketamine that was followed by continuous ketamine infusion at 20mg per hour for one hour. Optional morphine (4 mg) was offered at 20, 40 and 60 minutes. Pain intensity was assessed at regular intervals for 2 hours using a 10-point verbal numerical rating scale (NRS), along with vital signs and levels of sedation. Results showed that fifteen patients reported clinically significant pain relief at 60 minutes and 13 at 120 minutes; and eighteen patients reported mild or modest side effects including dizziness, fatigue and headache.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Procedure: Ketamine
IV Push or or IV Drip
Study Arms  ICMJE
  • Active Comparator: IV Push Group
    Ketamine medication given via IV Push. IV Push is the intervention.
    Intervention: Procedure: Ketamine
  • Active Comparator: IV Drip Group
    Ketamine medication given via IV Drip. IV Drip is the intervention.
    Intervention: Procedure: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Emergency Medicine patients
  • Adult patients (18-65 years of age)
  • Moderate to severe pain (Numeric Pain Rating Score =5).
  • Patients must be awake, alert and oriented to time, place and person.
  • Patients must be able to demonstrate understanding of the informed consent, and also able to verbalize how much pain they are having on the 10 point Numeric Rating Pain Scale, and the nature of the side effects they may be experiencing from the IV analgesia

Exclusion Criteria:

  • Patients with cognitive deficits that are not able to demonstrate understanding as described above.
  • Patient's reported weight of less than 45kg or more than 115kg.
  • Patients with altered mental status, alcohol intoxication, eye trauma.
  • Patients with hemodynamic instability (Systolic Blood pressure <90), and malignant hypertension.
  • allergy to ketamine
  • Pregnancy or breast feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02363270
Other Study ID Numbers  ICMJE 2014-10-08-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Antonios Likourezos, Maimonides Medical Center
Study Sponsor  ICMJE Antonios Likourezos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergey Motov, MD Maimonides Medical Center
Study Chair: John Marshall, MD Maimonides Medical Center
Study Director: Christian Fromm, MD Maimonides Medical Center
PRS Account Maimonides Medical Center
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP