Ketamine on Acute Pain in Females and Males

July 3, 2011 updated by: Ullevaal University Hospital

Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars

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

Study Overview

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

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, NO-0407
        • Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • saline physiological 5 ml
Active Comparator: Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine males
0,1 mg/kg ketamine iv bolus males
Other Names:
  • Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine males
0,3 mg/kg ketamine iv bolus males
Other Names:
  • Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine males
0,5 mg/kg ketamine iv bolus males
Other Names:
  • Ketalar ATC-nr.: N01A X03
Placebo Comparator: Placebo females
Saline physiological as placebo females
Intravenous saline bolus (Placebo-control) females
Other Names:
  • Saline physiological 5 ml
Active Comparator: Ketamine 0.1 mg/kg females
0,1 mg/kg ketamine females
0,1 mg/kg iv bolus ketamine females
Other Names:
  • Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,3 mg/kg females
0,3 mg/kg ketamine females
0,3 mg/kg iv bolus ketamine females
Other Names:
  • Ketalar ATC-nr.: N01A X03
Active Comparator: Ketamine 0,5 mg/kg females
0,5 mg/kg ketamine females
0,5 mg/kg iv bolus ketamine females
Other Names:
  • Ketalar ATC-nr.: N01A X03

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

October 2, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

April 1, 2008

More Information

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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