ACTRN12614000543684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 changes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1) Adult burn patients aged 18-65 years requiring at least two anticipated dressing changes of likely duration at least 20 minutes and anticipated to be sufficiently painful that procedural analgesia is clinically indicated.
- •2) Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
- •3) Agree to and be capable of understanding and signing an Informed Consent Form.
排除标准
- •1) Cirrhosis or other evidence of clinically significant disorder in hepatic function, as determined by the Investigator.
- •2) Renal impairment as evidenced by estimated creatinine clearance (CrCL), from the Cockcroft-Gault method, of less than 30 mL/min.
- •3) Any condition in which a significant elevation of blood pressure would be hazardous, e.g. severe cardiovascular disease, heart failure, severe or poorly controlled hypertension, recent myocardial infarction, current stroke or cerebral trauma, intracerebral mass or haemorrhage.
- •4) History of hypersensitivity to ketamine or any of the excipients.
- •5) Suspected increased cerebrospinal fluid pressure.
- •6) Glaucoma.
- •7) Current (within the last six months) major affective disorder, as assessed by the Investigator.
- •8) Uncontrolled hyperthyroidism.
- •9) Acute intermittent porphyria.
- •10) Pregnant or breastfeeding women.
- •11) Participation in another clinical trial of an investigational agent within 30 days of entry into the present trial.
研究者
相似试验
进行中（未招募）
不适用
Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammatiopatients with abdominal pain as a result of chronic pancreatitisMedDRA version: 13.1Level: PTClassification code 10033649Term: Pancreatitis chronicSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 13.1Level: LLTClassification code 10009093Term: Chronic pancreatitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-000647-24-NLRadboud University Nijmegen Medical Centre
已完成
2 期
The safety, tolerability, and analgesic efficacy of Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal paiChronic pancreatitisviscerale pijnchronic pancreas inflammation10015674NL-OMON35767niversitair Medisch Centrum Sint Radboud24
进行中（未招募）
4 期
Comparative study of analgesic efficacy between phosphate codeine in combination with paracetamol and oxycodone hydrochloride, after extractions of impacted lower third molars.postoperative pain13896RBR-8ntwmyqniversidade Federal de Juiz de Fora
进行中（未招募）
不适用
ASSESSMENT OF THE ANALGESIC EFFICACY AND TOLERABILITY OF THE PERIOPERATIVE ASSOCIATION OF KETAMINE WITH OPIATES AFTER POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSISPOSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSISMedDRA version: 14.1Level: LLTClassification code 10036804Term: Progressive infantile idiopathic scoliosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-000407-41-ESFUNDACIÓ SANT JOAN DE DE
已完成
不适用
Comparison of Pain relieving effect of Etoricoxib with Paracetamol Vs Ibuprofen with Paracetamol after tooth extractioCTRI/2020/09/027587Gajra Raja Medical college160