Ketamine on Acute Pain in Females and Males - Tabular View

Tracking Information

First Received Date ^ICMJE

September 30, 2005

Last Updated Date

June 15, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sum pain NRS [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Sum pain NRS

Change History

Complete list of historical versions of study NCT00232492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Several subjective variables assessing psychotomimetic effects [ Time Frame: 0, 15, 60 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Several subjective variables assessing psychotomimetic effects

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Pharmacodynamics Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, 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 / Comparison Groups

Placebo males: Placebo Comparator
Saline physiological placebo males

Intervention: Drug: Placebo males
Ketamine 0,1 mg/kg males: Active Comparator
0,1 mg/kg ketamine males

Intervention: Drug: Ketamine 0,1 mg/kg males
Ketamine 0,3 mg/kg males: Active Comparator
0,3 mg/kg ketamine males

Intervention: Drug: Ketamine 0,3 mg/kg males
Ketamine 0,5 mg/kg males: Active Comparator
0,5 mg/kg ketamine males

Intervention: Drug: Ketamine 0,5 mg/kg males
Placebo females: Placebo Comparator
Saline physiological as placebo females

Intervention: Drug: Placebo females
Ketamine 0.1 mg/kg females: Active Comparator
0,1 mg/kg ketamine females

Intervention: Drug: Ketamine 0,1 mg/kg females
Ketamine 0,3 mg/kg females: Active Comparator
0,3 mg/kg ketamine females

Intervention: Drug: Ketamine 0,3 mg/kg females
Ketamine 0,5 mg/kg females: Active Comparator
0,5 mg/kg ketamine females

Intervention: Drug: Ketamine 0,5 mg/kg females

Publications *

Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358-60. No abstract available.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

128

Completion Date

November 2006

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

Gender

Both

Ages

20 Years to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00232492

Responsible Party

Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway

Study ID Numbers ^ICMJE

DOK-015

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway

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

Information Provided By

Ullevaal University Hospital

Verification Date

April 2008

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