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Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02916927
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Eben Clattenburg, Alameda Health System

Brief Summary:

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects.

Study design: prospective, randomized, controlled, double-blind trial.


Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine IV Infusion Drug: Ketamine IV push Phase 4

Detailed Description:

Objective: The purpose of this randomized, controlled, double-blind trial is to evaluate if sub-dissociated dose ketamine given as an infusion versus an intravenous (IV) push over 1 minute has fewer and/or less severe adverse drug reactions and provides equivalent analgesia for patients with moderate to severe pain in the emergency department (ED).

Study design: Prospective, randomized, controlled, double-blind trial

Participants: Research assistants will recruit patients ≥18 years old with moderate to severe pain (NRS≥5) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed based on prior data which suggests that 60% of IV push arm and 20 % of infusion arm will have adverse drug reactions. investigators assume an alpha of 0.05 and a power of 0.8, which results in 56 patients needing to be enrolled.

Intervention: After a trained research assistant obtains written informed consent, pharmacists will randomize the participants to the IV push or IV infusion arm of the study. All patients will be placed on a cardiac monitor. All patients will receive and IV push over 1 minute and a 100 mL normal saline minibag over 15 minutes.

In the IV push arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 10 mL syringe and a 100 mL normal saline minibag. The nurse will start the minibag of normal saline and then administer the IV push of ketamine over 1 minute.

In the IV infusion arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 100 mL normal saline minibag and a 10 mL syringe of normal saline. The nurse will start the minibag of normal saline and then administer the IV push over 1 minute.

Data collection: The trained research assistant will collect data on the patients' pain scores, adverse drug reactions (presence, severity, and how bothersome they are), and vital signs.

Statistical analysis: Investigators will perform descriptive statistics, compare the proportion of patients with side effects, compare the severity of the side effects scores, and compare how bothersome the side effects.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department: A Prospective, Randomized, Double-blind Placebo Controlled Trial
Study Start Date : September 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine IV infusion
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Drug: Ketamine IV Infusion
Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
Other Name: Ketalar

Active Comparator: Ketamine IV push
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Drug: Ketamine IV push
Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
Other Name: Ketalar




Primary Outcome Measures :
  1. Side effects [ Time Frame: 0 - 60 minutes ]
    The difference in proportion of participants endorsing side effects between each arm of the study over 60 minutes.


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 5, 10, 15, 20, 30, 45, 60 minutes ]
    The difference in proportion of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.

  2. Side effect severity [ Time Frame: 5, 10, 15, 20, 30, 45, 60 minutes ]
    The difference in severity of side effects (1-5 scale) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.

  3. How bothersome are the side effects? [ Time Frame: 5, 10, 15, 20, 30, 45, 60 minutes ]
    The difference in how bothersome (1-5 scale) the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes.

  4. Reduction in pain [ Time Frame: 5, 10 , 15, 20, 30, 45, 60 minutes ]
    The difference in pain score (NRS 0-1) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain NRS ≥5
  • Anticipated stay in ED ≥1 hour

Exclusion Criteria:

  • Pregnant or breast feeding
  • Vital sign abnormalities (SBP <90, SBP > 180, HR < 50, HR > 150, RR <10, RR > 30, weight <45 kg, weight > 115 kg)
  • Arrhythmias
  • Altered mental status (active psychosis/delirium)
  • Administration of opioid pain medication in previous 1 hour
  • history of acute head or ocular trauma
  • presence of known intracranial mass or vascular lesion

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): NCT02916927


Locations
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United States, California
Alameda Health System, Highland Hospital
Oakland, California, United States, 94602
Sponsors and Collaborators
Alameda Health System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eben Clattenburg, Investigator, Alameda Health System
ClinicalTrials.gov Identifier: NCT02916927     History of Changes
Other Study ID Numbers: 00002
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eben Clattenburg, Alameda Health System:
ketamine
emergency department

Additional relevant MeSH terms:
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Ketamine
Emergencies
Disease Attributes
Pathologic Processes
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