Reversal of Ketamine Pharmacodynamic Effects With Naloxone

Sponsor

Ullevaal University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00921765

Collaborator

University of Oslo (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Saline Drug: Saline + Ketamine Drug: Naloxone + Placebo Drug: Naloxone + Ketamine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallell Group design should be used when final dose had been foundParallell 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

Official Title:

Naloxone Block of Low-dose (Analgetic Dose) Ketamine

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

Pain intensity (0-10 Numerical Rating Scale) [30 minutes]

Secondary Outcome Measures

Subjective measurement of psychotomimetic effects [30 minutes]
Adverse effects [30 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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