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Reversal of Ketamine Pharmacodynamic Effects With Naloxone

Information source: Ullevaal University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Saline (Drug); Saline + Ketamine (Drug); Naloxone + Placebo (Drug); Naloxone + Ketamine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ullevaal University Hospital

Official(s) and/or principal investigator(s):
Olav Hustveit, MD, PhD, Study Director, Affiliation: University of Oslo
Elena Landari, DDS, Principal Investigator, Affiliation: University of Oslo

Overall contact:
Lasse A Skoglund, DDS, DSci, Phone: 004722844672, Email: lasses@odont.uio.no


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

Clinical Details

Official title: Naloxone Block of Low-dose (Analgetic Dose) Ketamine

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Pain intensity (0-10 Numerical Rating Scale)

Secondary outcome:

Subjective measurement of psychotomimetic effects

Adverse effects

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.


Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Female.


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

Locations and Contacts

Lasse A Skoglund, DDS, DSci, Phone: 004722844672, Email: lasses@odont.uio.no

Ullevaal University Hospital, Oslo NO-0407, Norway; Recruiting
Lasse A Skoglund, DDS, DSci, Phone: 004722844672, Email: lasses@odont.uio.no
Per Skjelbred, DDS, MD, PhD, Phone: 004722118484, Email: p.skjelbred@ulleval.no
Elena Landari, DDS, Principal Investigator
Olav Hustveit, MD, PhD, Sub-Investigator
Lasse A Skoglund, DDS, DSci, Sub-Investigator
Additional Information

Related publications:

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.

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.

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):215-20.

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.

Starting date: June 2009
Last updated: March 2, 2010

Page last updated: August 23, 2015

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