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
Summary
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 effectsAdverse 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Female.
Criteria:
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
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