Reversal of Ketamine Pharmacodynamic Effects With Naloxone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00921765
First received: June 15, 2009
Last updated: March 2, 2010
Last verified: March 2010

June 15, 2009
March 2, 2010
June 2009
December 2010   (final data collection date for primary outcome measure)
Pain intensity (0-10 Numerical Rating Scale) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921765 on ClinicalTrials.gov Archive Site
  • Subjective measurement of psychotomimetic effects [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Reversal of Ketamine Pharmacodynamic Effects With Naloxone
Naloxone Block of Low-dose (Analgetic Dose) Ketamine

The purpose of this study is to determine whether the analgetic and other effects effect of ketamine are partly mediated through opioid receptors

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Pain
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 30 Years
No
Contact: Lasse A Skoglund, DDS, DSci 004722844672 lasses@odont.uio.no
Contact: Per Skjelbred, MD, DDS, PhD 004722118484 p.skjelbred@ulleval.no
Norway
 
NCT00921765
DOK-018
No
Professor Lasse A. Skoglund, Ullevaal University Hospital
Ullevaal University Hospital
University of Oslo
Study Director: Olav Hustveit, MD, PhD University of Oslo
Principal Investigator: Elena Landari, DDS University of Oslo
Ullevaal University Hospital
March 2010

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