- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232492
Ketamine on Acute Pain in Females and Males
Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, NO-0407
- Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Indication for removal of third molar
- Between 20 and 30 years of age
- ASA Class 1
Exclusion Criteria:
- Psychiatric family (father/mother) or own anamnestic history
- Hypersensitivity towards NSAIDS or other rescue analgesics
- Verified or suspected pregnancy
- Lactating females
- Surgery lasting over 60 min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo males
Saline physiological placebo males
|
Intravenous saline bolus (Placebo-control) males
Other Names:
|
Active Comparator: Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine males
|
0,1 mg/kg ketamine iv bolus males
Other Names:
|
Active Comparator: Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine males
|
0,3 mg/kg ketamine iv bolus males
Other Names:
|
Active Comparator: Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine males
|
0,5 mg/kg ketamine iv bolus males
Other Names:
|
Placebo Comparator: Placebo females
Saline physiological as placebo females
|
Intravenous saline bolus (Placebo-control) females
Other Names:
|
Active Comparator: Ketamine 0.1 mg/kg females
0,1 mg/kg ketamine females
|
0,1 mg/kg iv bolus ketamine females
Other Names:
|
Active Comparator: Ketamine 0,3 mg/kg females
0,3 mg/kg ketamine females
|
0,3 mg/kg iv bolus ketamine females
Other Names:
|
Active Comparator: Ketamine 0,5 mg/kg females
0,5 mg/kg ketamine females
|
0,5 mg/kg iv bolus ketamine females
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sum pain NRS
Time Frame: 60 min
|
60 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Several subjective variables assessing psychotomimetic effects
Time Frame: 0, 15, 60
|
0, 15, 60
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Tooth, Impacted
- Tooth Diseases
- Stomatognathic Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- DOK-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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