Ketamine on Acute Pain in Females and Males

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tooth, Impacted, Mouth and Tooth Diseases

Intervention / Treatment
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* 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
* Drug: Ketamine 0,1 mg/kg females
* Drug: Ketamine 0,3 mg/kg females
* Drug: Ketamine 0,5 mg/kg females


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo males<br>Saline physiological placebo males | Drug: Placebo males<br>* Intravenous saline bolus (Placebo-control) males<br>* Other names: saline physiological 5 ml;|
| Active Comparator: Ketamine 0,1 mg/kg males<br>0,1 mg/kg ketamine males | Drug: Ketamine 0,1 mg/kg males<br>* 0,1 mg/kg ketamine iv bolus males<br>* Other names: Ketalar ATC-nr.: N01A X03;|
| Active Comparator: Ketamine 0,3 mg/kg males<br>0,3 mg/kg ketamine males | Drug: Ketamine 0,3 mg/kg males<br>* 0,3 mg/kg ketamine iv bolus males<br>* Other names: Ketalar ATC-nr.: N01A X03;|
| Active Comparator: Ketamine 0,5 mg/kg males<br>0,5 mg/kg ketamine males | Drug: Ketamine 0,5 mg/kg males<br>* 0,5 mg/kg ketamine iv bolus males<br>* Other names: Ketalar ATC-nr.: N01A X03;|
| Placebo Comparator: Placebo females<br>Saline physiological as placebo females | Drug: Placebo females<br>* Intravenous saline bolus (Placebo-control) females<br>* Other names: Saline physiological 5 ml;|
| Active Comparator: Ketamine 0.1 mg/kg females<br>0,1 mg/kg ketamine females | Drug: Ketamine 0,1 mg/kg females<br>* 0,1 mg/kg iv bolus ketamine females<br>* Other names: Ketalar ATC-nr.: N01A X03;|
| Active Comparator: Ketamine 0,3 mg/kg females<br>0,3 mg/kg ketamine females | Drug: Ketamine 0,3 mg/kg females<br>* 0,3 mg/kg iv bolus ketamine females<br>* Other names: Ketalar ATC-nr.: N01A X03;|
| Active Comparator: Ketamine 0,5 mg/kg females<br>0,5 mg/kg ketamine females | Drug: Ketamine 0,5 mg/kg females<br>* 0,5 mg/kg iv bolus ketamine females<br>* Other names: Ketalar ATC-nr.: N01A X03;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum pain NRS |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Several subjective variables assessing psychotomimetic effects |  | 0, 15, 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wisdom, Tooth, Teeth, Third, Molar