Ketamine Analgesia in Third Molar Surgery

PHASE4CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

February 14, 2017

Primary Completion Date

March 10, 2022

Study Completion Date

September 30, 2022

Conditions
PainPostoperative
Interventions
DRUG

S-Ketamine

"Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.~All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed."

DRUG

Sodium Chloride 0.9% Inj

"Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.~All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed."

Trial Locations (1)

79182

Käkkirurgiska kliniken, Falu lasarett, Falun

All Listed Sponsors
collaborator

Uppsala University

OTHER

collaborator

Center for Clinical Research Dalarna, Sweden

OTHER

lead

Dalarna County Council, Sweden

OTHER