Ketamine Analgesia in Third Molar Surgery
Condition: Pain; Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      BACKGROUND AND PURPOSE Outpatient surgery (day case surgery) is increasing. When the patients
      go home on the same day, this demands safe pain relief. A reduction of morphine (opioid) use
      is sought because of side effects and the dependency risk. An effective alternative to
      opioids is ketamine, which lacks the side effects of opioids but provides powerful analgesic
      effects.

      METHOD At the start of surgery, Ketamine or placebo will be given in a vein to evaluate if
      the acute pain decreases significantly. Inflammation is known to cause pain. By measuring
      different proteins in the blood, the investigators want to understand how inflammation links
      to the pain. Wisdom tooth surgery provides significant post-operative pain and is a widely
      accepted pain model in drug studies. Patients referred for wisdom tooth surgery are asked to
      participate in the study. For statistical certainty, in total 165 persons will be enrolled to
      three groups. Two with active drug (different dose) and one placebo. Everyone gets local
      anesthesia. The completion of the study will be done in four years. The Ethics Review Board
      has approved the study.

      CLINICAL RELEVANCE Effective pain relief after daily surgical procedures is important for
      patient´s safety and reducing the risk of long-term pain. It is also ethically necessary for
      the continued expansion of day case surgery. New knowledge of the mechanisms of pain
      increases the opportunities for individual and safe pain relief. Day case surgery is
      performed in all operating specialties, this might affects many patients nationally and
      internationally.
    


Intervention name(s): S-Ketamine; Sodium Chloride 0.9% Inj
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Ketamine; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Postoperative; Pain management; Third molar