跳至主要内容
临床试验/NCT04459377
NCT04459377已完成4 期

An Analysis of Ketamine Analgesia in Third Molar Surgery -Effects, Safety and Influence on Inflammatory Biomarkers in Plasma

Dalarna County Council, Sweden1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年2月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Pain (VAS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy or mild well-compensated systemic disease (ASA I & II)
  • 18- <45 years
  • 50-100 kg body weight

排除标准

  • 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
  • Hyperthyreosis
  • Myasthenia gravis
  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

Sodium Chloride solution (9mg / ml) 0.2ml / kg slow intravenous injection (2ml / min).

干预措施: Sodium Chloride 0.9% Inj (Drug)

K1

Active Comparator

S-Ketamine (0.125 mg / kg body weight). (0.625mg / ml x 0.2ml / kg) slow intravenous injection (2ml / min).

干预措施: S-Ketamine (Drug)

K2

Active Comparator

S-Ketamine (0.25 mg / kg body weight). (1.25mg / ml x 0.2ml / kg) slow intravenous injection (2ml / min).

干预措施: S-Ketamine (Drug)

结局指标

主要结局

Pain (VAS)

时间窗: 4 hours postoperatively

Postoperative pain measured by Visual analog scale (VAS). From minimum 0mm to maximum 100mm. 0mm is no pain and 100mm is worst pain imaginable. Changes in Visual Analog Scale value from preoperatively to 4 hours postoperatively

次要结局

  • Safety (Oxygen saturation)(Up to 2 hours.)

研究者

发起方
Dalarna County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Eriksson

Senior Consultant in Oral and Maxillofacial Surgery

Dalarna County Council, Sweden

研究点 (1)

Loading locations...

相似试验