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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo males | Placebo Comparator | Saline physiological placebo males |
|
| Ketamine 0,1 mg/kg males | Active Comparator | 0,1 mg/kg ketamine males |
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| Ketamine 0,3 mg/kg males | Active Comparator | 0,3 mg/kg ketamine males |
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| Ketamine 0,5 mg/kg males | Active Comparator | 0,5 mg/kg ketamine males |
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| Placebo females | Placebo Comparator | Saline physiological as placebo females |
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| Ketamine 0.1 mg/kg females | Active Comparator | 0,1 mg/kg ketamine females |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo males | Drug | Intravenous saline bolus (Placebo-control) males |
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| Measure | Description | Time Frame |
|---|---|---|
| Sum pain NRS | 60 min |
| Measure | Description | Time Frame |
|---|---|---|
| Several subjective variables assessing psychotomimetic effects | 0, 15, 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lasse A Skoglund, DDS, PhD | Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway | Study Chair |
| Olav Hustveit, MD | Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital | Oslo | NO-0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8351166 | Background | Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available. | |
| Background | Øye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991. |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
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| Ketamine 0,3 mg/kg females | Active Comparator | 0,3 mg/kg ketamine females |
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| Ketamine 0,5 mg/kg females | Active Comparator | 0,5 mg/kg ketamine females |
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| Ketamine 0,1 mg/kg males | Drug | 0,1 mg/kg ketamine iv bolus males |
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| Ketamine 0,3 mg/kg males | Drug | 0,3 mg/kg ketamine iv bolus males |
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| Ketamine 0,5 mg/kg males | Drug | 0,5 mg/kg ketamine iv bolus males |
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| Placebo females | Drug | Intravenous saline bolus (Placebo-control) females |
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| Ketamine 0,1 mg/kg females | Drug | 0,1 mg/kg iv bolus ketamine females |
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| Ketamine 0,3 mg/kg females | Drug | 0,3 mg/kg iv bolus ketamine females |
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| Ketamine 0,5 mg/kg females | Drug | 0,5 mg/kg iv bolus ketamine females |
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