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Sponsors and Collaborators: |
Ullevaal University Hospital Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00232492 |
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
Condition | Intervention | Phase |
---|---|---|
Mouth and Tooth Diseases Tooth, Impacted |
Drug: placebo Drug: ketamine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars |
Enrollment: | 128 |
Study Start Date: | January 2005 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Drug (including placebo) Placebo males
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Drug: placebo
intravenous saline (Placebo-control) males
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2: Active Comparator
0,1 mg/kg ketamine males
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Drug: ketamine
0,1 mg/kg ketamine iv bolus males
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3: Active Comparator
0,3 mg/kg ketamine males
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Drug: ketamine
0,3 mg/kg ketamine iv bolus males
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4: Active Comparator
0,5 mg/kg ketamine males
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Drug: ketamine
0,5 mg/kg ketamine iv bolus males
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5: Placebo Comparator
Drug (including placebo) Placebo females
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Drug: Placebo
intravenous saline iv bolus (Placebo-control) females
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6: Active Comparator
0,1 mg/kg ketamine females
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Drug: ketamine
0,1 mg/kg iv bolus ketamine females
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7: Active Comparator
0,3 mg/kg ketamine females
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Drug: ketamine
0,3 mg/kg iv bolus ketamine females
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8: Active Comparator
0,5 mg/kg ketamine females
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Drug: ketamine
0,5 mg/kg iv bolus ketamine females
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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.
Ages Eligible for Study: | 20 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital | |
oslo, Norway, NO-0407 |
Study Chair: | Lasse A Skoglund, DDS, PhD | Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway |
Principal Investigator: | Olav Hustveit, MD | Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway |
Responsible Party: | Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway ( Professor Lasse A. Skoglund ) |
Study ID Numbers: | DOK-015 |
Study First Received: | September 30, 2005 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00232492 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
Wisdom Tooth Teeth Third Molar |
Excitatory Amino Acids Tooth Diseases Ketamine |
Pain Stomatognathic Diseases Tooth, Impacted |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative |
Pharmacologic Actions Sensory System Agents Anesthetics, General Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |