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

Pain control in surgical intervention. Biomarkers in acute and chronical post operative pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004235-39-SE

Enrollment

165

Registered

2016-06-22

Start date

2016-08-06

Completion date

Unknown

Last updated

2022-03-21

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

Conditions

Post operative pain MedDRA version: 19.0 Level: PT Classification code 10051059 Term: Oral surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.0 Level: LLT Classification code 10036237 Term: Post operative analgesia System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ketanest Pharmaceutical Form: Intravesical solution/solution for injection Pharmaceutical form of the placebo: Intravesical solution/solution for injection Route of administration of the p

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

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

Countries

Sweden

Contacts

Public ContactKäkkirurgiska kliniken

Folktandvården, Landstinget Dalarna

+46023492409

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026