Ketamine on Acute Pain in Females and Males

Tooth, Impacted Clinical Trial

Official title:

Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232492
• Other study ID #: DOK-015
• 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

Related Conditions & MeSH terms

• Mouth and Tooth Diseases
• Stomatognathic Diseases
• Tooth Diseases
• Tooth, Impacted

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