Ketamine on Acute Pain in Females and Males - Full Text View

Sponsor:	Ullevaal University Hospital
Collaborator:	Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00232492

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 IV

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:

MedlinePlus related topics: Tooth Disorders

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

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

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:

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.

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: The National Committees for Research Ethics in Norway

Keywords provided by Oslo University Hospital:

Wisdom
Tooth
Teeth
Third
Molar

Additional relevant MeSH terms:

Stomatognathic Diseases
Tooth Diseases
Tooth, Impacted
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012