Ketamine on Acute Pain in Females and Males

Phase 4

Completed

• Conditions: Mouth and Tooth Diseases; Tooth, Impacted
• Interventions: Drug: Ketamine 0,1 mg/kg females; Drug: Ketamine 0,3 mg/kg females; Drug: Ketamine 0,5 mg/kg females; Drug: Placebo males; Drug: Ketamine 0,1 mg/kg males; Drug: Ketamine 0,3 mg/kg males; Drug: Ketamine 0,5 mg/kg males; Drug: Placebo females

• Registration Number: NCT00232492
• Lead Sponsor: Ullevaal University Hospital

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-10-02
• Study First Posted: 2005-10-04
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-04
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine 0.1 mg/kg females	Ketamine 0,1 mg/kg females	0,1 mg/kg ketamine females
Ketamine 0,3 mg/kg females	Ketamine 0,3 mg/kg females	0,3 mg/kg ketamine females
Ketamine 0,5 mg/kg females	Ketamine 0,5 mg/kg females	0,5 mg/kg ketamine females
Placebo males	Placebo males	Saline physiological placebo males
Ketamine 0,1 mg/kg males	Ketamine 0,1 mg/kg males	0,1 mg/kg ketamine males
Ketamine 0,3 mg/kg males	Ketamine 0,3 mg/kg males	0,3 mg/kg ketamine males
Ketamine 0,5 mg/kg males	Ketamine 0,5 mg/kg males	0,5 mg/kg ketamine males
Placebo females	Placebo females	Saline physiological as placebo females

Primary Outcome Measures

Name	Time	Method
Sum pain NRS	60 min

Secondary Outcome Measures

Name	Time	Method
Several subjective variables assessing psychotomimetic effects	0, 15, 60

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital; 🇳🇴 Oslo, Norway