NCT00232492

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 6, 2011

Status Verified

April 1, 2008

Enrollment Period

1.8 years

First QC Date

September 30, 2005

Last Update Submit

July 3, 2011

Conditions

Mouth and Tooth DiseasesTooth, Impacted

Keywords

WisdomToothTeethThirdMolar

Outcome Measures

Primary Outcomes (1)

  • Sum pain NRS

    60 min

Secondary Outcomes (1)

  • Several subjective variables assessing psychotomimetic effects

    0, 15, 60

Study Arms (8)

Placebo males

PLACEBO COMPARATOR

Saline physiological placebo males

Drug: Placebo males

Ketamine 0,1 mg/kg males

ACTIVE COMPARATOR

0,1 mg/kg ketamine males

Drug: Ketamine 0,1 mg/kg males

Ketamine 0,3 mg/kg males

ACTIVE COMPARATOR

0,3 mg/kg ketamine males

Drug: Ketamine 0,3 mg/kg males

Ketamine 0,5 mg/kg males

ACTIVE COMPARATOR

0,5 mg/kg ketamine males

Drug: Ketamine 0,5 mg/kg males

Placebo females

PLACEBO COMPARATOR

Saline physiological as placebo females

Drug: Placebo females

Ketamine 0.1 mg/kg females

ACTIVE COMPARATOR

0,1 mg/kg ketamine females

Drug: Ketamine 0,1 mg/kg females

Ketamine 0,3 mg/kg females

ACTIVE COMPARATOR

0,3 mg/kg ketamine females

Drug: Ketamine 0,3 mg/kg females

Ketamine 0,5 mg/kg females

ACTIVE COMPARATOR

0,5 mg/kg ketamine females

Drug: Ketamine 0,5 mg/kg females

Interventions

Placebo malesDRUG

Intravenous saline bolus (Placebo-control) males

Also known as: saline physiological 5 ml
Placebo males
Ketamine 0,1 mg/kg malesDRUG

0,1 mg/kg ketamine iv bolus males

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0,1 mg/kg males
Ketamine 0,3 mg/kg malesDRUG

0,3 mg/kg ketamine iv bolus males

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0,3 mg/kg males
Ketamine 0,5 mg/kg malesDRUG

0,5 mg/kg ketamine iv bolus males

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0,5 mg/kg males
Placebo femalesDRUG

Intravenous saline bolus (Placebo-control) females

Also known as: Saline physiological 5 ml
Placebo females
Ketamine 0,1 mg/kg femalesDRUG

0,1 mg/kg iv bolus ketamine females

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0.1 mg/kg females
Ketamine 0,3 mg/kg femalesDRUG

0,3 mg/kg iv bolus ketamine females

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0,3 mg/kg females
Ketamine 0,5 mg/kg femalesDRUG

0,5 mg/kg iv bolus ketamine females

Also known as: Ketalar ATC-nr.: N01A X03
Ketamine 0,5 mg/kg females

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indication for removal of third molar
  • Between 20 and 30 years of age
  • ASA Class 1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (2)

  • 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.

    PMID: 8351166BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Stomatognathic DiseasesTooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases

Study Officials

  • Lasse A Skoglund, DDS, PhD

    Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway

    STUDY CHAIR

  • Olav Hustveit, MD

    Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

July 6, 2011

Record last verified: 2008-04

Locations

NO(1)