Reversal of Ketamine Pharmacodynamic Effects With Naloxone

NCT00921765 | Terminated Phase 4

• 1 other identifier: DOK-018
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

Pain; Naloxone; Ketamine; Third Molar; Surgery

Outcome Measures

Primary Outcomes (1)

• Pain intensity (0-10 Numerical Rating Scale)

  30 minutes

Secondary Outcomes (2)

• Subjective measurement of psychotomimetic effects

  30 minutes

• Adverse effects

  30 minutes

Study Arms (4)

Placebo + Placebo

PLACEBO COMPARATOR

Saline single bolus dose iv + saline single bolus dose iv

Drug: Saline

Placebo + Ketamine

ACTIVE COMPARATOR

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

Drug: Saline + Ketamine

Naloxone + Placebo

ACTIVE COMPARATOR

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

Drug: Naloxone + Placebo

Naloxone + Ketamine

ACTIVE COMPARATOR

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

Interventions

Saline DRUG

Saline single bolus dose followed by saline single bolus dose iv

Also known as: Physiological saline 0.9%

Placebo + Placebo

Saline + Ketamine DRUG

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

Also known as: Physiological saline 0.9%, Ketamine, ATC code: N01A X03

Placebo + Ketamine

Naloxone + Placebo DRUG

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

Also known as: Naloxone, ATC code: V03A B15, Physiological saline 0.9%

Naloxone + Placebo

Naloxone + Ketamine DRUG

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

Also known as: Naloxone, ATC code: V03A B15, Ketamine, ATC code: N01A X03

Naloxone + Ketamine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females of norwegian Caucasian origin who needs surgical removal of impacted third molars

You may not qualify if:

• 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

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Ullevaal University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (4)

• Gear RW, Miaskowski C, Gordon NC, Paul SM, Heller PH, Levine JD. Kappa-opioids produce significantly greater analgesia in women than in men. Nat Med. 1996 Nov;2(11):1248-50. doi: 10.1038/nm1196-1248.

  PMID: 8898754 BACKGROUND

• Hustveit O, Maurset A, Oye I. Interaction of the chiral forms of ketamine with opioid, phencyclidine, sigma and muscarinic receptors. Pharmacol Toxicol. 1995 Dec;77(6):355-9. doi: 10.1111/j.1600-0773.1995.tb01041.x.

  PMID: 8835358 BACKGROUND

• Mathisen LC, Skjelbred P, Skoglund LA, Oye I. Effect of ketamine, an NMDA receptor inhibitor, in acute and chronic orofacial pain. Pain. 1995 May;61(2):215-220. doi: 10.1016/0304-3959(94)00170-J.

  PMID: 7659431 BACKGROUND

• Oye I, Paulsen O, Maurset A. Effects of ketamine on sensory perception: evidence for a role of N-methyl-D-aspartate receptors. J Pharmacol Exp Ther. 1992 Mar;260(3):1209-13.

  PMID: 1312163 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride; Ketamine; Naloxone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Olav Hustveit, MD, PhD

  University of Oslo

  STUDY DIRECTOR

• Elena Landari, DDS

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind (one making drug solutions) another administrating the drugs
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)