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Reversal of Ketamine Pharmacodynamic Effects With Naloxone

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ClinicalTrials.gov Identifier: NCT00921765
Recruitment Status : Terminated (Problems with patient recruitment)
First Posted : June 16, 2009
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Lasse Ansgar Skoglund, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE June 15, 2009
First Posted Date  ICMJE June 16, 2009
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
Pain intensity (0-10 Numerical Rating Scale) [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
  • Subjective measurement of psychotomimetic effects [ Time Frame: 30 minutes ]
  • Adverse effects [ Time Frame: 30 minutes ]
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 Reversal of Ketamine Pharmacodynamic Effects With Naloxone
Official Title  ICMJE Naloxone Block of Low-dose (Analgetic Dose) Ketamine
Brief Summary The purpose of this study is to determine whether the analgetic and other effects effect of ketamine are partly mediated through opioid receptors
Detailed Description Ketamine er et dissociative anaesthetic closely related with phencyclidine (PCP). Phencyclidine is a non-competitive NMDA-antagonist, and it is assumed that the pharmacodynamic mechanism of action for ketamine is the same. Receptor binding studies shows that ketamine has affinity to many receptor types, including opioid mu and kappa receptors. Ketamine has only about 25 times lower affinity for kappa receptors than for the NMDA-receptor complex. Naloxone is a specific antagonist for opioid receptors and block both mu og kappa receptors. A dose of naloxone 10 times larger than required to block mu receptors is required to block kappa receptors. Experiments with naloxone suggest that ketamine is not a mu agonist, but experiments with sufficient large naloxone doses to block kappa receptors have not been carried out in humans.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallell Group design should be used when final dose had been found
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind (one making drug solutions) another administrating the drugs
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Saline
    Saline single bolus dose followed by saline single bolus dose iv
    Other Name: Physiological saline 0.9%
  • Drug: Saline + Ketamine
    Single bolus dose of saline followed by ketamine 0.2 mg/kg bw
    Other Names:
    • Physiological saline 0.9%
    • Ketamine
    • ATC code: N01A X03
  • Drug: Naloxone + Placebo
    Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
    Other Names:
    • Naloxone
    • ATC code: V03A B15
    • Physiological saline 0.9%
  • Drug: Naloxone + Ketamine
    Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw
    Other Names:
    • Naloxone
    • ATC code: V03A B15
    • Ketamine
    • ATC code: N01A X03
Study Arms  ICMJE
  • Placebo Comparator: Placebo + Placebo
    Saline single bolus dose iv + saline single bolus dose iv
    Intervention: Drug: Saline
  • Active Comparator: Placebo + Ketamine
    Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw
    Intervention: Drug: Saline + Ketamine
  • Active Comparator: Naloxone + Placebo
    Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
    Intervention: Drug: Naloxone + Placebo
  • Active Comparator: Naloxone + Ketamine
    Single bolus dose of ketamine 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw
    Intervention: Drug: Naloxone + 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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2009)
64
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females of norwegian Caucasian origin who needs surgical removal of impacted third molars

Exclusion Criteria:

  • Anamnestic information regarding psychiatric diagnosis regarding mother/father or brother/sister Concommitant medication other than oral contraceptives Hypersensitivity towards NSAID/opioids/study drugs Females with suspected or confirmed pregnancy Lactating females Surgery lasting more than 60 minutes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921765
Other Study ID Numbers  ICMJE DOK-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lasse Ansgar Skoglund, Oslo University Hospital
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE University of Oslo
Investigators  ICMJE
Study Director: Olav Hustveit, MD, PhD University of Oslo
Principal Investigator: Elena Landari, DDS University of Oslo
PRS Account Oslo University Hospital
Verification Date April 2018

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