Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Sum pain NRS
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo males
Saline physiological placebo males
Intervention: Placebo males (Drug)
Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine males
Intervention: Ketamine 0,1 mg/kg males (Drug)
Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine males
Intervention: Ketamine 0,3 mg/kg males (Drug)
Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine males
Intervention: Ketamine 0,5 mg/kg males (Drug)
Placebo females
Saline physiological as placebo females
Intervention: Placebo females (Drug)
Ketamine 0.1 mg/kg females
0,1 mg/kg ketamine females
Intervention: Ketamine 0,1 mg/kg females (Drug)
Ketamine 0,3 mg/kg females
0,3 mg/kg ketamine females
Intervention: Ketamine 0,3 mg/kg females (Drug)
Ketamine 0,5 mg/kg females
0,5 mg/kg ketamine females
Intervention: Ketamine 0,5 mg/kg females (Drug)
Outcomes
Primary Outcomes
Sum pain NRS
Time Frame: 60 min
Secondary Outcomes
- Several subjective variables assessing psychotomimetic effects(0, 15, 60)