Reversal of Ketamine Pharmacodynamic Effects With Naloxone

Phase 4

Terminated

• Conditions: Pain
• Interventions: Drug: Naloxone + Ketamine; Drug: Naloxone + Placebo; Drug: Saline + Ketamine; Drug: Saline

• Registration Number: NCT00921765
• Lead Sponsor: Ullevaal University Hospital

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 Timeline

• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Study Start: 2009-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naloxone + Ketamine	Naloxone + Ketamine	Single bolus dose of ketamine 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw
Naloxone + Placebo	Naloxone + Placebo	Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
Placebo + Ketamine	Saline + Ketamine	Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw
Placebo + Placebo	Saline	Saline single bolus dose iv + saline single bolus dose iv

Primary Outcome Measures

Name	Time	Method
Pain intensity (0-10 Numerical Rating Scale)	30 minutes

Secondary Outcome Measures

Name	Time	Method
Subjective measurement of psychotomimetic effects	30 minutes
Adverse effects	30 minutes

Trial Locations

Locations (1)

Ullevaal University Hospital; 🇳🇴 Oslo, Norway