EUCTR2021-003258-21-DK进行中（未招募）1 期
Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 after Impacted Mandibular Third Molar Extraction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy (The American Society of Anaesthesiologists’ Physical Classification System (ASA) I-II) male or female participants scheduled
- •for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.
- •2. Ability to understand spoken and written Danish
- •3. Written informed consent for participation in the study
- •4. Age: > 18 and < 55 years
- •5. Body Mass index above (>)18.5 or below (<) 30.0 kg/m2
- •6. Physical examination, including blood pressure, pulse rate, ECG and laboratory assessment without clinically significant abnormalities. A
- •potential participant with measurements outside of the reference range for the population being studied may be included at the investigator´s
- •discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures.
- •7. A woman of childbearing potential is eligible to participate if she is not pregnant, nor breastfeeding, and agrees to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment
- •8. Prior to randomisation: Numeric Pain Rating Scale (NRS anchored by 0 = no pain”, 10 = worst pain imaginable”) = 5 at rest within 4 hours after the administration of the last dose of local anaesthetic
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when
- •participating in the study, or influence the potential subject’s ability to participate in the study or influence the study results.
- •2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely
- •to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure
- •3. History of increased bleeding tendency
- •4. Clinically significant mental illness
- •5. Opioid Risk Tool score of >3
- •6. Pain Catastrophizing Scale score, total points >30
- •7. Hospital Anxiety and Depression Scale (HADS), points =11 for anxiety or
- •=11 points for depression
- •8. Daily intake of analgesics
- •9. Daily use of tobacco, including snuff
- •10. History of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of the investigational medicinal product.
- •11. Use of prescription drugs within 14 days (including low-dose acetylsalicylic acid [<150 mg/day]) or over-the-counter drugs 24 hours
- •except paracetamol, which is allowed until 6 pm the day before surgery (intranasal medication 48 hours, ibuprofen max 400 mg/day) prior to the
- •first dose of study medication, unless it is the opinion of the Investigator that the medication will not interfere with the study procedures or
- •compromise the participant.
- •12. Any scheduled invasive treatment or medical/surgical procedure during the study period, except surgical removal of an impacted mandibular third
- •13. Abnormal nasal cavity/airway such as: a. evidence of previous significant nasal disorder including
- •surgery, or dependence of inhaled drug b. current significant nasal congestion due to common cold
- •c. minimum air flow during the nasal passages (evaluated at the investigator’s discretion)
- •14. History or presence of hypersensitivity or allergy to sufentanil, ketamine, NSAIDs or local anaesthetics, a history of anaphylactic or anaphylactoid
- •reactions, or a history of other allergy that, in the opinion of the investigator, contraindicates the participation.
- •15. Positive COVID-19 test or clinical symptoms of COVID-19 (testing of potential participants will follow the health authorities’ guidelines and
- •current local guidelines)
- •16. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial
- •17. Previous randomisation to treatment in the present study
- •18. Blood or plasma donation within 4 weeks prior to the dosing procedure visit (Visit 3 [Day 0]).
- •19. Chronic pain as judged by the investigator
研究者
相似试验
招募中
2 期
The analgesic efficacy, tolerability, safety and pharmacokinetics of a sublingual wafer formulation of ketamine in burns patients undergoing painful dressing changesBurnsAnaesthesiology - Pain managementInjuries and Accidents - BurnsACTRN12614000543684Ix Biopharma Pty Ltd40
已完成
不适用
Evaluation of analgesic effect of analgesic agents used perioperatively.Patients included are greater than 20 years of age, scheduled for surgery.JPRN-UMIN000014879Department of Anesthesiology and Resuscitology, Shinshu University School of medicine100
招募中
不适用
comparison of three different technique of pain relief in one sided abdominal hernia surgeryCTRI/2014/09/005023VMMMC AND SAFDARJUNG HOSPITAL NEW DELHI120
尚未招募
不适用
COMPARISON BETWEEN TWO ANAESTHETIC TECHNIQUE USED IN MICRO SURGERY OF SHOULDER JOINT IN TERMS OF PAIN RELIEF AND COMPLICATIONS.CTRI/2023/02/049921KPC MEDICAL COLLEGE AND HOSPITA
尚未招募
4 期
A comparative study of two types of pain relieving nerve blockade techniques(erector spinae block and pectoral nerve block) in terms of pain relief during and after surgery, and the comfort level of patients while performing the nerve blockade procedure in patients undergoing breast cancer surgeryCTRI/2023/09/057261Dr Anita Sharma