Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Visual Analog scale (VAS)
研究概览
简要总结
The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients.
In earlier studies the median VAS during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between ages 1year to 18 years
- •A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist
排除标准
- •Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
研究组 & 干预措施
Intranasal dexmedetomidine
Dexmedetomidine is given once 4 micrograms per kilogram intranasally. If the sedation is not successful another 2 microgram per kilogram intranasal dose is given. Intravenous dexmedetomidine solution is administrated intranasally with MAD nasal drug delivery device and a syringe.
干预措施: Dexmedetomidine (Drug)
Intranasal dexmedetomidine
Dexmedetomidine is given once 4 micrograms per kilogram intranasally. If the sedation is not successful another 2 microgram per kilogram intranasal dose is given. Intravenous dexmedetomidine solution is administrated intranasally with MAD nasal drug delivery device and a syringe.
干预措施: Sedatives/Hypnotics,Other (Drug)
Nitrous oxide inhalation
Dinitrousoxide (N2O) is given with Livopan administrating device. Livopan consists of 50% oxygen and 50% nitrous oxide. Gas mixture is inhaled 5 minutes before the injection procedure and during the injection procedure.
干预措施: Dexmedetomidine (Drug)
Nitrous oxide inhalation
Dinitrousoxide (N2O) is given with Livopan administrating device. Livopan consists of 50% oxygen and 50% nitrous oxide. Gas mixture is inhaled 5 minutes before the injection procedure and during the injection procedure.
干预措施: Sedatives/Hypnotics,Other (Drug)
结局指标
主要结局
Visual Analog scale (VAS)
时间窗: The VAS score is assessed after procedure when the patients have recovered from the sedation and are being discharged. The time of discharge is 1 to 5 hours after the injection procedure.
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.
次要结局
- Visual Analog scale (VAS)(At the follow up visit which usually is 2-12 weeks after the injection.)
- Blood pressure(Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.)
- Respiratory rate(Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.)
- COMFORT-B(Assessed 20 minutes before the drug administration and in every 15 minutes for six hours after the drug administration and during the injection procedure and 5 and 10 minutes after the injection.)
- Capnometry(Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.)
- Pulse oxymetry(Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.)
- Heart rate(Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.)
- FLACC(Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.)
研究者
Outi Peltoniemi
PhD, Senior physician in Oulu University Hospital at the Department of Pediatrics (PICU)
University of Oulu