Ketamine: Comparison of IV Push vs. IV Drip

October 19, 2017 updated by: Antonios Likourezos

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IV Push Group
Ketamine medication given via IV Push. IV Push is the intervention.
Procedure: Ketamine
IV Push or or IV Drip
Active Comparator: IV Drip Group
Ketamine medication given via IV Drip. IV Drip is the intervention.
Procedure: Ketamine
IV Push or or IV Drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Investigators

  • Study Director: Christian Fromm, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

August 15, 2016

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-10-08-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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