Pain management in wisdomtooth surgery. Changes in blood sampel due toacute and chronical pain.

Phase 1

• Conditions: Post operative pain; MedDRA version: 19.0Level: PTClassification code 10051059Term: Oral surgerySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: LLTClassification code 10036237Term: Post operative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-004235-39-SE
• Lead Sponsor: Folktandvården, Landstinget Dalarna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-22
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Healthy or mild systemic disease (ASA I or II)
Age 18-44 years
Body weight: 50-100kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 165
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Medication: analgetics, hypnotics (the last week before inclusion),
thyroid hormones, psychopharmaceutics or MAO-inhibitors.
Hypertension [>150/95 mmHg at screening ]
Heartfailure
Psychosis
Epilepsy
Hyperthyreosis
Myastenia gravis
Glaukoma
Sleepapnea
Diabetes (Type I)
Porfyria
Pregnancy
Nursing
Blood disease (Hepatitis A, B and HIV)
Unable to understand spoken or written information in swedish
Known allergy against: midazolam, ketamine, ibuprofen, or local
anesthesia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate effect of preemptive s-ketamine in subanesthetical dosage on acute and chronical post operative pain in third molar sugery.;Secondary Objective: To identify biomarkers that predicts or variates in association with pain experience.<br><br>To study the risk of developing chronical pain after third molar sugery;Primary end point(s): VAS registration during the first 24h post operative;Timepoint(s) of evaluation of this end point: At the end of inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain questionaire (by Telephone);Timepoint(s) of evaluation of this end point: 6 months post operative