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Completed

NCT Number: NCT00232492

Ketamine on Acute Pain in Females and Males

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

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Key information

Conditions

Mouth and Tooth Diseases Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Oslo, NO-0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo males

Drug

Intravenous saline bolus (Placebo-control) males

Other names: saline physiological 5 ml

Ketamine 0,1 mg/kg males

Drug

0,1 mg/kg ketamine iv bolus males

Other names: Ketalar ATC-nr.: N01A X03

Ketamine 0,3 mg/kg males

Drug

0,3 mg/kg ketamine iv bolus males

Other names: Ketalar ATC-nr.: N01A X03

Ketamine 0,5 mg/kg males

Drug

0,5 mg/kg ketamine iv bolus males

Other names: Ketalar ATC-nr.: N01A X03

Placebo females

Drug

Intravenous saline bolus (Placebo-control) females

Other names: Saline physiological 5 ml

Ketamine 0,1 mg/kg females

Drug

0,1 mg/kg iv bolus ketamine females

Other names: Ketalar ATC-nr.: N01A X03

Ketamine 0,3 mg/kg females

Drug

0,3 mg/kg iv bolus ketamine females

Other names: Ketalar ATC-nr.: N01A X03

Ketamine 0,5 mg/kg females

Drug

0,5 mg/kg iv bolus ketamine females

Other names: Ketalar ATC-nr.: N01A X03

Primary outcomes

  1. Sum pain NRS

    Time frame: 60 min

Secondary outcomes

  1. Several subjective variables assessing psychotomimetic effects

    Time frame: 0, 15, 60

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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