Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920528
Recruitment Status : Active, not recruiting
First Posted : September 30, 2016
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Air Force Research Laboratory
Information provided by (Responsible Party):
David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Tracking Information
First Submitted Date  ICMJE September 28, 2016
First Posted Date  ICMJE September 30, 2016
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
Compare pain relief between the 3 treatment groups as measured by the VAS. A decrease of at least 20mm on the VAS will be considered "significant" pain relief [ Time Frame: 1 hour ]
Subjects pain will be assessed by VAS at 20, 40 and 60 minutes. Differences at 60 minutes will be compared for the primary outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02920528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Compare total dosage of IV hydromorphone needed as rescue therapy to achieved adequate pain relief [ Time Frame: 1 hour ]
    Compare need for rescue therapy at the completion of the 1 hour study
  • Assess the risk for complications of sub-dissociative dose ketamine [ Time Frame: 1 hour ]
    Subjects will be continuously assessed for complications secondary to the sub-dissociative ketamine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain
Official Title  ICMJE Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain: A Randomized Controlled Trial
Brief Summary This is a prospective, randomized controlled trial which will be conducted to determine whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with chronic pain syndrome presenting to the emergency department with exacerbation of their chronic pain. The investigators also aim to determine whether use of SDDK can reduce the amount of subsequent opioid pain medications required for adequate pain relief in this population.
Detailed Description
  1. The informed consent process will be initiated by investigators in the emergency department.
  2. All potential subjects will be informed that participation in the study could lead to a positive urine drug test that could remain positive for up to a month after the conclusion of the study.
  3. Female subjects of child bearing age, will have a pregnancy test performed prior to enrollment; any subjects who are pregnant will be excluded from this project.
  4. Each subject will be asked to grade his/her pain severity on a 100mm non-hatched visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst, maximum pain).
  5. Each subject will be asked to fill out a baseline pain questionnaire
  6. Each subject will be placed on monitors for continuous pulse oximetry, Heart Rate, Respiratory Rate, and blood pressure every 5 minutes for the duration of the study of one hour and longer for any patient who needs continued care. The patients temperature will be taken prior to the start of the protocol.
  7. Each subject will have an intravenous catheter placed.
  8. Each subject will be sequentially assigned to one of three treatment groups, based on a computer-generated randomization schedule, to receive an intravenous infusion of sub-dissociative Ketamine (0.25mg/kg), sub-dissociative dose Ketamine (0.5mg/kg), or an equal amount of normal saline.
  9. All medications will be prepared by an emergency department pharmacist and all study medication intravenous bags will be identical in appearance and will be administered by the emergency department nurse caring for the patient who will be blinded to the study drug.
  10. Each subject will receive lightly tinted sunglasses to wear during the duration of the study to minimize bias as ketamine can evoke a tell-tale short- lived nystagmus
  11. Each subject will receive the study medication over a 20 minute period via an automated pump. At this point, the subjects will be asked to rate their pain on a VAS and asked if they need additional pain medication that will consist of intravenous hydromorphone with the dose and frequency determined by the discretion of the treating physician and documented on the data collection sheet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Ketamine
    sub-dissociative ketamine
    Other Name: ketalar
  • Drug: Placebo
    Normal Saline
    Other Name: Normal Saline
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo controlled arm
    Intervention: Drug: Placebo
  • Experimental: very low dose ketamine
    0.25 mg/kg of sub-dissociative ketamine as an experimental arm
    Intervention: Drug: Ketamine
  • Experimental: low dose ketamine
    0.50 mg/kg of sub-dissociative ketamine as an experimental arm
    Intervention: Drug: Ketamine
Publications * Lumanauw DD, Youn S, Horeczko T, Yadav K, Tanen DA. Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain. Acad Emerg Med. 2019 Sep;26(9):1044-1051. doi: 10.1111/acem.13755. Epub 2019 Apr 29.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
106
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
96
Estimated Study Completion Date  ICMJE October 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All adult subjects over the age of 18 with chronic pain* presenting to the emergency department with exacerbation of their chronic pain as their primary complaint
  • Subjects who are willing and able to provide informed consent. *Chronic pain defined as greater > 3 months of symptoms and an initial VAS pain score > 70

Exclusion Criteria:

  • History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder, inability to provide informed consent: dementia, non-English/Spanish speakers, subjects in custody, suicidal, or clinically intoxicated.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02920528
Other Study ID Numbers  ICMJE 30612-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Sponsor  ICMJE Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators  ICMJE Air Force Research Laboratory
Investigators  ICMJE
Principal Investigator: David Tanen, MD Los Angeles Biomedical Institute
PRS Account Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verification Date July 2018

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