Ketamine Analgesia in Third Molar Surgery
关键词
抽象
日期
最后验证: | 06/30/2020 |
首次提交: | 06/30/2020 |
提交的预估入学人数: | 06/30/2020 |
首次发布: | 07/06/2020 |
上次提交的更新: | 07/12/2020 |
最近更新发布: | 07/14/2020 |
实际学习开始日期: | 02/13/2017 |
预计主要完成日期: | 11/30/2022 |
预计完成日期: | 11/30/2023 |
状况或疾病
干预/治疗
Drug: S-Ketamine
Drug: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Placebo Comparator: Placebo Sodium Chloride solution (9mg / ml) 0.2ml / kg slow intravenous injection (2ml / min). | Drug: Placebo 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. |
Active Comparator: K1 S-Ketamine (0.125 mg / kg body weight). (0.625mg / ml x 0.2ml / kg) slow intravenous injection (2ml / min). | |
Active Comparator: K2 S-Ketamine (0.25 mg / kg body weight). (1.25mg / ml x 0.2ml / kg) slow intravenous injection (2ml / min). |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Healthy or mild well-compensated systemic disease (ASA I & II) - 18- <45 years - 50-100 kg body weight Exclusion Criteria: - Medication drugs: analgesics, hypnotics (the last week before surgery), thyroid hormones, psychoactive drugs or monoamine oxidase inhibitors (MAO inhibitors). - Hypertension [> 150/95 mmHg in screening study] - Heart failure - Psychosis - Epilepsy - Hyperthyreosis - Myasthenia gravis - Glaucoma - Verified sleep apnea - Diabetes (insulin treated) - Porphyria - Pregnancy - Breast-feeding - Blood transmitted infections, such as HIV and hepatitis B and C - Known hypersensitivity to midazolam, ketamine, ibuprofen, or local anesthetics - Inability to obtain the requisite written or oral information |
结果
主要结果指标
1. Pain (VAS) [4 hours postoperatively]
次要成果指标
1. Safety (Oxygen saturation) [Up to 2 hours.]