Reversal of Ketamine Pharmacodynamic Effects With Naloxone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind (one making drug solutions) another administrating the drugs

Study Groups

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Placebo + Placebo

Saline single bolus dose iv + saline single bolus dose iv

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline single bolus dose followed by saline single bolus dose iv

Placebo + Ketamine

Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw

Group Type ACTIVE_COMPARATOR

Saline + Ketamine

Intervention Type DRUG

Single bolus dose of saline followed by ketamine 0.2 mg/kg bw

Naloxone + Placebo

Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline

Group Type ACTIVE_COMPARATOR

Naloxone + Placebo

Intervention Type DRUG

Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline

Naloxone + Ketamine

Single bolus dose of ketamine 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw

Group Type ACTIVE_COMPARATOR

Naloxone + Ketamine

Intervention Type DRUG

Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw

Interventions

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Saline

Saline single bolus dose followed by saline single bolus dose iv

Intervention Type DRUG

Saline + Ketamine

Single bolus dose of saline followed by ketamine 0.2 mg/kg bw

Intervention Type DRUG

Naloxone + Placebo

Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Physiological saline 0.9% Physiological saline 0.9% Ketamine ATC code: N01A X03 Naloxone ATC code: V03A B15 Physiological saline 0.9% Naloxone ATC code: V03A B15 Ketamine ATC code: N01A X03

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No