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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00232492
Other study ID # DOK-015
Secondary ID
Status Completed
Phase Phase 4
First received September 30, 2005
Last updated July 3, 2011
Start date January 2005
Est. completion date November 2006

Study information

Verified date April 2008
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 30 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Placebo males
Intravenous saline bolus (Placebo-control) males
Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine iv bolus males
Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine iv bolus males
Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine iv bolus males
Placebo females
Intravenous saline bolus (Placebo-control) females
Ketamine 0,1 mg/kg females
0,1 mg/kg iv bolus ketamine females
Ketamine 0,3 mg/kg females
0,3 mg/kg iv bolus ketamine females
Ketamine 0,5 mg/kg females
0,5 mg/kg iv bolus ketamine females

Locations

Country Name City State
Norway Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Ullevaal University Hospital University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sum pain NRS 60 min No
Secondary Several subjective variables assessing psychotomimetic effects 0, 15, 60 No
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