Ketamine on Acute Pain in Females and Males

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

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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