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Ketamine on Acute Pain in Females and Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00232492
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Mouth and Tooth Diseases Tooth, Impacted Drug: Placebo males Drug: Ketamine 0,1 mg/kg males Drug: Ketamine 0,3 mg/kg males Drug: Ketamine 0,5 mg/kg males Drug: Placebo females Drug: Ketamine 0,1 mg/kg females Drug: Ketamine 0,3 mg/kg females Drug: Ketamine 0,5 mg/kg females Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Study Start Date : January 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo males
Saline physiological placebo males
 Drug: Placebo males
Intravenous saline bolus (Placebo-control) males
Other Name: saline physiological 5 ml
Active Comparator: Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine males
 Drug: Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine iv bolus males
Other Name: Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine males
 Drug: Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine iv bolus males
Other Name: Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine males
 Drug: Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine iv bolus males
Other Name: Ketalar ATC-nr.: N01A X03
Placebo Comparator: Placebo females
Saline physiological as placebo females
 Drug: Placebo females
Intravenous saline bolus (Placebo-control) females
Other Name: Saline physiological 5 ml
Active Comparator: Ketamine 0.1 mg/kg females
0,1 mg/kg ketamine females
 Drug: Ketamine 0,1 mg/kg females
0,1 mg/kg iv bolus ketamine females
Other Name: Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,3 mg/kg females
0,3 mg/kg ketamine females
 Drug: Ketamine 0,3 mg/kg females
0,3 mg/kg iv bolus ketamine females
Other Name: Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,5 mg/kg females
0,5 mg/kg ketamine females
 Drug: Ketamine 0,5 mg/kg females
0,5 mg/kg iv bolus ketamine females
Other Name: Ketalar ATC-nr.: N01A X03


Outcome Measures
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Primary Outcome Measures :
  1. Sum pain NRS [ Time Frame: 60 min ]

Secondary Outcome Measures :
  1. Several subjective variables assessing psychotomimetic effects [ Time Frame: 0, 15, 60 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232492


Locations
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Norway
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, Norway, NO-0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Investigators
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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
More Information
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Publications:
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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Responsible Party: Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
ClinicalTrials.gov Identifier: NCT00232492    
Other Study ID Numbers: DOK-015
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: April 2008
Keywords provided by Oslo University Hospital:
Wisdom
Tooth
Teeth
Third
Molar
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action