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Ketamine on Acute Pain in Females and Males

U

Ullevaal University Hospital

Status and phase

Completed
Phase 4

Conditions

Mouth and Tooth Diseases
Tooth, Impacted

Treatments

Drug: Ketamine 0,1 mg/kg females
Drug: Placebo males
Drug: Ketamine 0,3 mg/kg males
Drug: Placebo females
Drug: Ketamine 0,5 mg/kg males
Drug: Ketamine 0,3 mg/kg females
Drug: Ketamine 0,1 mg/kg males
Drug: Ketamine 0,5 mg/kg females

Study type

Interventional

Funder types

Other

Identifiers

NCT00232492
DOK-015

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

All

Ages

20 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

128 participants in 8 patient groups, including a placebo group

Placebo males
Placebo Comparator group
Description:
Saline physiological placebo males
Treatment:
Drug: Placebo males
Ketamine 0,1 mg/kg males
Active Comparator group
Description:
0,1 mg/kg ketamine males
Treatment:
Drug: Ketamine 0,1 mg/kg males
Ketamine 0,3 mg/kg males
Active Comparator group
Description:
0,3 mg/kg ketamine males
Treatment:
Drug: Ketamine 0,3 mg/kg males
Ketamine 0,5 mg/kg males
Active Comparator group
Description:
0,5 mg/kg ketamine males
Treatment:
Drug: Ketamine 0,5 mg/kg males
Placebo females
Placebo Comparator group
Description:
Saline physiological as placebo females
Treatment:
Drug: Placebo females
Ketamine 0.1 mg/kg females
Active Comparator group
Description:
0,1 mg/kg ketamine females
Treatment:
Drug: Ketamine 0,1 mg/kg females
Ketamine 0,3 mg/kg females
Active Comparator group
Description:
0,3 mg/kg ketamine females
Treatment:
Drug: Ketamine 0,3 mg/kg females
Ketamine 0,5 mg/kg females
Active Comparator group
Description:
0,5 mg/kg ketamine females
Treatment:
Drug: Ketamine 0,5 mg/kg females

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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