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临床试验/NCT03053947
NCT03053947已完成2 期

Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial

Evelyne D.Trottier2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.

研究概览

简要总结

Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED.

There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 to 12 years;
  • Weight between 10 and 30 kg
  • Any laceration requiring sutures repair;
  • Need for procedural sedation according to the emergency physician assessment for the suture repair

排除标准

  • American Society of Anesthesiologists (ASA) physical status class III and more;
  • Previous administration of IV, IN or oral analgesics or opioid other than acetaminophen and ibuprofen;
  • Allergy or previous adverse reaction to ketamine;
  • Aberrant nasal anatomy or nasal trauma;
  • Presence of multiple trauma or eye rupture suspicion
  • Head injury with loss of consciousness, decreased Glasgow Coma Scale (GCS) or intracranial bleeding;
  • Cognitive impairment;
  • Known glaucoma;
  • Language barrier
  • Known schizophrenia or psychotic event;
  • Uncontrolled hypertension;
  • Airway instability (tracheal surgery, tracheal stenosis, tracheomalacia, and laryngomalacia)
  • Active pulmonary infections (including upper respiratory infections)
  • Known or suspected cardiac disease
  • Known or suspected kidney disease

研究组 & 干预措施

Ketamine IN

Other

All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.

干预措施: Intranasal Ketamine (Drug)

结局指标

主要结局

DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.

时间窗: 18 months

Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair

DosINK 2- Evaluation of the dose determined in DosINK 1 of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.

时间窗: 18 months

Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients

次要结局

  • Parents, patients and provider satisfaction with sedation as assessed by Likert scale.(18 months)
  • Pain before, during and after the procedure assessed with the Faces pain scale Revised for children older than 4 year-old and with the Face Legs Activity Cry Consolability (FLACC) score for children younger than 4 year-old.(18 months)
  • Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).(18 months)
  • Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.(18 months)
  • Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.(18 months)

研究者

发起方
Evelyne D.Trottier
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Evelyne D.Trottier

M.D., FRCPC

St. Justine's Hospital

研究点 (2)

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