Ketamine on Acute Pain in Females and Males

Ketamine

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

Intervention / Treatment

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

Condition or Disease

  • Mouth and Tooth Diseases
  • Tooth, Impacted

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 20 Years to 30 Years
Enrollment: 128 (ACTUAL)
Funded by: Other
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Jan 01, 2005
Primary Completion: Nov 01, 2006 ACTUAL
Completion Date: Nov 01, 2006 ACTUAL
Study First Posted: Oct 04, 2005 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Jul 03, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Oslo, Norway

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.

Eligibility Criteria

Sex: All
Minimum Age: 20
Maximum Age: 30
Healthy Volunteers: Yes

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

Primary Outcomes
  • Sum pain NRS 60 min
Secondary Outcomes
  • Several subjective variables assessing psychotomimetic effects 0, 15, 60

More Details

NCT Number: NCT00232492
Other IDs: DOK-015
Study URL: https://clinicaltrials.gov/study/NCT00232492
Last updated: Sep 29, 2023