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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
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: Saline
Drug: Saline + Ketamine
Drug: Naloxone + Placebo
Drug: Naloxone + Ketamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Naloxone Block of Low-dose (Analgetic Dose) Ketamine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Pain intensity (0-10 Numerical Rating Scale) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Placebo
Saline single bolus dose iv + saline single bolus dose iv
 Drug: Saline
Saline single bolus dose followed by saline single bolus dose iv
Other Name: Physiological saline 0.9%
Active Comparator: Placebo + Ketamine
Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw
 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
Active Comparator: Naloxone + Placebo
Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
 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%
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
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921765

Contacts
Contact: Lasse A Skoglund, DDS, DSci 004722844672 lasses@odont.uio.no
Contact: Per Skjelbred, MD, DDS, PhD 004722118484 p.skjelbred@ulleval.no

Locations
Norway
Ullevaal University Hospital Recruiting
Oslo, Norway, NO-0407
Contact: Lasse A Skoglund, DDS, DSci     004722844672     lasses@odont.uio.no    
Contact: Per Skjelbred, DDS, MD, PhD     004722118484     p.skjelbred@ulleval.no    
Principal Investigator: Elena Landari, DDS            
Sub-Investigator: Olav Hustveit, MD, PhD            
Sub-Investigator: Lasse A Skoglund, DDS, DSci            
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Investigators
Study Director: Olav Hustveit, MD, PhD University of Oslo
Principal Investigator: Elena Landari, DDS University of Oslo
  More Information

Publications:

Responsible Party: Professor Lasse A. Skoglund, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00921765     History of Changes
Other Study ID Numbers: DOK-018
Study First Received: June 15, 2009
Last Updated: March 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Keywords provided by Ullevaal University Hospital:
Pain
Naloxone
Ketamine
Third Molar
Surgery

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

ClinicalTrials.gov processed this record on May 23, 2013