Ketamine on Acute Pain in Females and Males

Ullevaal University Hospital128 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

128

Conditions

Mouth and Tooth Diseases Tooth, Impacted

Interventions

Placebo malesDRUG

Intravenous saline bolus (Placebo-control) males

Ketamine 0,1 mg/kg malesDRUG

0,1 mg/kg ketamine iv bolus males

Ketamine 0,3 mg/kg malesDRUG

0,3 mg/kg ketamine iv bolus males

Eligibility

Sex: ALLMin age: 20 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Sum pain NRS

Time frame: 60 min

Secondary Outcomes

Several subjective variables assessing psychotomimetic effects

Time frame: 0, 15, 60

Data from ClinicalTrials.gov

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