Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Success of the procedure
研究概览
简要总结
The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
排除标准
- •Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
- •II or III degree AV-blockage without pacemaker
- •Uncontrollable hypotension
- •Critically ill patients who are admitted to the PICU
- •Patients with clear cardiac or respiratory dysfunction
- •Lowered level of consciousness
- •Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
- •A single patient can only take part in this study once.
研究组 & 干预措施
Dexmedetomidine
1µg/kg intranasal dexmedetomidine
干预措施: Intranasal Drug (Drug)
Placebo
0,01ml/kg intranasal 4,5% saline
干预措施: Intranasal Drug (Drug)
结局指标
主要结局
Success of the procedure
时间窗: After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.
The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.
次要结局
- Patient sedation level(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
- Respiratory rate(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
- Duration of crying(Duration of crying during the time period from 25 minutes after the study drug administration for 30 minute time period in which the procedure is anticipated to be done.)
- Oxygen saturation(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
- Attempts needed to complete the procedure(After the successful attempt of the procedure. The first attempt of the procedure is done 30 minutes after the study drug administration. The assessment is done within 2 hours of the administration of the study drug.)
- Patient pain FLACC(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
- Blood pressure(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
- The duration of the procedure(The time from the start of the first attempt of the procedure to the success of the procedure. The procedure is attempted 30 after the study drug administration. Time from the first needle puncture to ending the procedure is recorded.)
- Parents assessment of the patients pain during the procedure(Parents return a questionnaire within 2 hours after the study drug has been administered.)
- Patient pain VAS(The numerical value of VAS is asked in the end of the follow up period of 2 hours.)
- Effectivity of the drug(The follow up period lasts 2 hours from the study drug administration.)
- Heart rate(Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.)
研究者
Outi Peltoniemi
Adjunct Professor of Pediatric Intensive Care
University of Oulu