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

Sponsors and Collaborators:	Ullevaal University Hospital Section of dental Pharmacology and Pharmacotherapy, University of Oslo, Norway
Information provided by:	Ullevaal 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 Drug: ketamine Drug: Placebo	Phase IV

MedlinePlus related topics: Tooth Disorders

Drug Information available for: Ketamine Ketamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars

Further study details as provided by Ullevaal 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
1: Placebo Comparator Drug (including placebo) Placebo males	Drug: placebo intravenous saline (Placebo-control) males
2: Active Comparator 0,1 mg/kg ketamine males	Drug: ketamine 0,1 mg/kg ketamine iv bolus males
3: Active Comparator 0,3 mg/kg ketamine males	Drug: ketamine 0,3 mg/kg ketamine iv bolus males
4: Active Comparator 0,5 mg/kg ketamine males	Drug: ketamine 0,5 mg/kg ketamine iv bolus males
5: Placebo Comparator Drug (including placebo) Placebo females	Drug: Placebo intravenous saline iv bolus (Placebo-control) females
6: Active Comparator 0,1 mg/kg ketamine females	Drug: ketamine 0,1 mg/kg iv bolus ketamine females
7: Active Comparator 0,3 mg/kg ketamine females	Drug: ketamine 0,3 mg/kg iv bolus ketamine females
8: Active Comparator 0,5 mg/kg ketamine females	Drug: ketamine 0,5 mg/kg iv bolus ketamine females

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:	Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway ( Professor Lasse A. Skoglund )
Study ID Numbers:	DOK-015
Study First Received:	September 30, 2005
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00232492
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

Wisdom
Tooth
Teeth
Third
Molar

Study placed in the following topic categories:

Excitatory Amino Acids
Tooth Diseases
Ketamine

Pain
Stomatognathic Diseases
Tooth, Impacted

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative

Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009