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Ketamine on Acute Pain in Females and Males

Primary Purpose

Mouth and Tooth Diseases, Tooth, Impacted

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Placebo males
Ketamine 0,1 mg/kg males
Ketamine 0,3 mg/kg males
Ketamine 0,5 mg/kg males
Placebo females
Ketamine 0,1 mg/kg females
Ketamine 0,3 mg/kg females
Ketamine 0,5 mg/kg females
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mouth and Tooth Diseases focused on measuring Wisdom, Tooth, Teeth, Third, Molar

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo males

Ketamine 0,1 mg/kg males

Ketamine 0,3 mg/kg males

Ketamine 0,5 mg/kg males

Placebo females

Ketamine 0.1 mg/kg females

Ketamine 0,3 mg/kg females

Ketamine 0,5 mg/kg females

Arm Description

Saline physiological placebo males

0,1 mg/kg ketamine males

0,3 mg/kg ketamine males

0,5 mg/kg ketamine males

Saline physiological as placebo females

0,1 mg/kg ketamine females

0,3 mg/kg ketamine females

0,5 mg/kg ketamine females

Outcomes

Primary Outcome Measures

Sum pain NRS

Secondary Outcome Measures

Several subjective variables assessing psychotomimetic effects

Full Information

First Posted
September 30, 2005
Last Updated
July 3, 2011
Sponsor
Ullevaal University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT00232492
Brief Title
Ketamine on Acute Pain in Females and Males
Official Title
Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth and Tooth Diseases, Tooth, Impacted
Keywords
Wisdom, Tooth, Teeth, Third, Molar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo males
Arm Type
Placebo Comparator
Arm Description
Saline physiological placebo males
Arm Title
Ketamine 0,1 mg/kg males
Arm Type
Active Comparator
Arm Description
0,1 mg/kg ketamine males
Arm Title
Ketamine 0,3 mg/kg males
Arm Type
Active Comparator
Arm Description
0,3 mg/kg ketamine males
Arm Title
Ketamine 0,5 mg/kg males
Arm Type
Active Comparator
Arm Description
0,5 mg/kg ketamine males
Arm Title
Placebo females
Arm Type
Placebo Comparator
Arm Description
Saline physiological as placebo females
Arm Title
Ketamine 0.1 mg/kg females
Arm Type
Active Comparator
Arm Description
0,1 mg/kg ketamine females
Arm Title
Ketamine 0,3 mg/kg females
Arm Type
Active Comparator
Arm Description
0,3 mg/kg ketamine females
Arm Title
Ketamine 0,5 mg/kg females
Arm Type
Active Comparator
Arm Description
0,5 mg/kg ketamine females
Intervention Type
Drug
Intervention Name(s)
Placebo males
Other Intervention Name(s)
saline physiological 5 ml
Intervention Description
Intravenous saline bolus (Placebo-control) males
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,1 mg/kg males
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,1 mg/kg ketamine iv bolus males
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,3 mg/kg males
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,3 mg/kg ketamine iv bolus males
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,5 mg/kg males
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,5 mg/kg ketamine iv bolus males
Intervention Type
Drug
Intervention Name(s)
Placebo females
Other Intervention Name(s)
Saline physiological 5 ml
Intervention Description
Intravenous saline bolus (Placebo-control) females
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,1 mg/kg females
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,1 mg/kg iv bolus ketamine females
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,3 mg/kg females
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,3 mg/kg iv bolus ketamine females
Intervention Type
Drug
Intervention Name(s)
Ketamine 0,5 mg/kg females
Other Intervention Name(s)
Ketalar ATC-nr.: N01A X03
Intervention Description
0,5 mg/kg iv bolus ketamine females
Primary Outcome Measure Information:
Title
Sum pain NRS
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Several subjective variables assessing psychotomimetic effects
Time Frame
0, 15, 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse A Skoglund, DDS, PhD
Organizational Affiliation
Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olav Hustveit, MD
Organizational Affiliation
Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
8351166
Citation
Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available.
Results Reference
background
Citation
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.
Results Reference
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Ketamine on Acute Pain in Females and Males

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