Ketamine on Acute Pain in Females and Males

This study has been completed.
Sponsor:
Collaborator:
Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00232492
First received: September 30, 2005
Last updated: July 3, 2011
Last verified: April 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Sum pain NRS [ Time Frame: 60 min ] [ Designated as safety issue: No ]

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

Enrollment: 128
Study Start Date: January 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232492

Locations
Norway
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, Norway, NO-0407
Sponsors and Collaborators
Ullevaal University Hospital
Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
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
  More Information

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.

Responsible Party: Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
ClinicalTrials.gov Identifier: NCT00232492     History of Changes
Other Study ID Numbers: DOK-015
Study First Received: September 30, 2005
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Wisdom
Tooth
Teeth
Third
Molar

Additional relevant MeSH terms:
Stomatognathic Diseases
Tooth Diseases
Tooth, Impacted
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014