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Problems with patient recruitment
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Placebo | Placebo Comparator | Saline single bolus dose iv + saline single bolus dose iv |
|
| Placebo + Ketamine | Active Comparator | Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw |
|
| Naloxone + Placebo | Active Comparator | Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Saline single bolus dose followed by saline single bolus dose iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (0-10 Numerical Rating Scale) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective measurement of psychotomimetic effects | 30 minutes | |
| Adverse effects | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olav Hustveit, MD, PhD | University of Oslo | Study Director |
| Elena Landari, DDS | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ullevaal University Hospital | Oslo | NO-0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8898754 | Background | 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. | |
| 8835358 | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007649 | Ketamine |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Parallell Group design should be used when final dose had been found
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Double blind (one making drug solutions) another administrating the drugs
| Saline + Ketamine | Drug | Single bolus dose of saline followed by ketamine 0.2 mg/kg bw |
|
|
| Naloxone + Placebo | Drug | Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline |
|
|
| 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 |
|
|
| 7659431 | 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. |
| 1312163 | 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. |
| D017670 |
| Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |