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A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

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ClinicalTrials.gov Identifier: NCT03274453
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.

Condition or disease Intervention/treatment Phase
Spinal Fusion Drug: Ketamine Drug: Saline Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double Blinded Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Actual Study Start Date : November 1, 2012
Actual Primary Completion Date : November 1, 2014
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine Naive

After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.

Infusion will be maintained for 24 hours.

Drug: Ketamine
0.12 mg/kg/hr of ketamine post surgery

Placebo Comparator: Naive Placebo
Saline will be administered at the same rate as the ketamine infusion. Infusion will be maintained for 24 hours.
Drug: Saline
Saline will be administered at the same rate as the ketamine infusion.

Placebo Comparator: Tolerant Placebo
Saline will be administered at the same rate as the ketamine infusion. Infusion will be maintained for 24 hours.
Drug: Saline
Saline will be administered at the same rate as the ketamine infusion.

Experimental: Tolerant Ketamine

After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.

Infusion will be maintained for 24 hours.

Drug: Ketamine
0.12 mg/kg/hr of ketamine post surgery




Primary Outcome Measures :
  1. Hydromorphone Use/24 Hours postOP in mg/kg [ Time Frame: 24 Hours ]
    Hydromorphone use during the first postoperative 24 hours in mg/kg



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
  • If female, subject is non-lactating and is either:
  • Not of childbearing potential
  • Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
  • Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

  • anxiety
  • psychiatric disorder
  • Allergy or sensitivity to ketamine or dilaudid
  • Deemed un-acceptable by study team
  • Cognitively impaired (by history)
  • Subject requires chronic antipsychotic medication
  • Subject known to be in liver failure
  • Subject for whom opioids or ketamine are contraindicated
  • Patients with narrow angle glaucoma
  • Patients with a history of psychosis

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): NCT03274453


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Kirsten Boenigk, MD Kirsten.Boenigk@nyumc.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03274453     History of Changes
Other Study ID Numbers: 12-02202
First Posted: September 7, 2017    Key Record Dates
Results First Posted: June 14, 2018
Last Update Posted: June 14, 2018
Last Verified: May 2018

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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
Additional relevant MeSH terms:
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Ketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action