Ketamine on Acute Pain in Females and Males

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232492

Enrollment

128

Registered

2005-10-04

Start date

2005-01-31

Completion date

2006-11-30

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mouth and Tooth Diseases, Tooth, Impacted

Keywords

Wisdom, Tooth, Teeth, Third, Molar

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.

Interventions

DRUGPlacebo males

Intravenous saline bolus (Placebo-control) males

DRUGKetamine 0,1 mg/kg males

0,1 mg/kg ketamine iv bolus males

DRUGKetamine 0,3 mg/kg males

0,3 mg/kg ketamine iv bolus males

DRUGKetamine 0,5 mg/kg males

0,5 mg/kg ketamine iv bolus males

DRUGPlacebo females

Intravenous saline bolus (Placebo-control) females

DRUGKetamine 0,1 mg/kg females

0,1 mg/kg iv bolus ketamine females

DRUGKetamine 0,3 mg/kg females

0,3 mg/kg iv bolus ketamine females

DRUGKetamine 0,5 mg/kg females

0,5 mg/kg iv bolus ketamine females

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame
Sum pain NRS	60 min

Secondary

Measure	Time frame
Several subjective variables assessing psychotomimetic effects	0, 15, 60

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026