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Ketamine on Acute Pain in Females and Males

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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

Tracking Information
First Submitted Date  ICMJE September 30, 2005
First Posted Date  ICMJE October 4, 2005
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE January 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Sum pain NRS [ Time Frame: 60 min ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2005)
Sum pain NRS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Several subjective variables assessing psychotomimetic effects [ Time Frame: 0, 15, 60 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2005)
Several subjective variables assessing psychotomimetic effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine on Acute Pain in Females and Males
Official Title  ICMJE Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mouth and Tooth Diseases
  • Tooth, Impacted
Intervention  ICMJE
  • Drug: Placebo males
    Intravenous saline bolus (Placebo-control) males
    Other Name: saline physiological 5 ml
  • Drug: Ketamine 0,1 mg/kg males
    0,1 mg/kg ketamine iv bolus males
    Other Name: Ketalar ATC-nr.: N01A X03
  • Drug: Ketamine 0,3 mg/kg males
    0,3 mg/kg ketamine iv bolus males
    Other Name: Ketalar ATC-nr.: N01A X03
  • Drug: Ketamine 0,5 mg/kg males
    0,5 mg/kg ketamine iv bolus males
    Other Name: Ketalar ATC-nr.: N01A X03
  • Drug: Placebo females
    Intravenous saline bolus (Placebo-control) females
    Other Name: Saline physiological 5 ml
  • Drug: Ketamine 0,1 mg/kg females
    0,1 mg/kg iv bolus ketamine females
    Other Name: Ketalar ATC-nr.: N01A X03
  • Drug: Ketamine 0,3 mg/kg females
    0,3 mg/kg iv bolus ketamine females
    Other Name: Ketalar ATC-nr.: N01A X03
  • Drug: Ketamine 0,5 mg/kg females
    0,5 mg/kg iv bolus ketamine females
    Other Name: Ketalar ATC-nr.: N01A X03
Study Arms  ICMJE
  • Placebo Comparator: Placebo males
    Saline physiological placebo males
    Intervention: Drug: Placebo males
  • Active Comparator: Ketamine 0,1 mg/kg males
    0,1 mg/kg ketamine males
    Intervention: Drug: Ketamine 0,1 mg/kg males
  • Active Comparator: Ketamine 0,3 mg/kg males
    0,3 mg/kg ketamine males
    Intervention: Drug: Ketamine 0,3 mg/kg males
  • Active Comparator: Ketamine 0,5 mg/kg males
    0,5 mg/kg ketamine males
    Intervention: Drug: Ketamine 0,5 mg/kg males
  • Placebo Comparator: Placebo females
    Saline physiological as placebo females
    Intervention: Drug: Placebo females
  • Active Comparator: Ketamine 0.1 mg/kg females
    0,1 mg/kg ketamine females
    Intervention: Drug: Ketamine 0,1 mg/kg females
  • Active Comparator: Ketamine 0,3 mg/kg females
    0,3 mg/kg ketamine females
    Intervention: Drug: Ketamine 0,3 mg/kg females
  • Active Comparator: Ketamine 0,5 mg/kg females
    0,5 mg/kg ketamine females
    Intervention: Drug: Ketamine 0,5 mg/kg females
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2008)
128
Original Enrollment  ICMJE
 (submitted: October 2, 2005)
80
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232492
Other Study ID Numbers  ICMJE DOK-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE University of Oslo
Investigators  ICMJE
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
PRS Account Oslo University Hospital
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP