Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Behavioral pain scale (COMFORT scale)
研究概览
简要总结
Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.
详细描述
management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. Acupuncture has shown its analgesic efficacy in numerous studies in children and adults. Acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents
Main objective:
Assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ETS) after surgery ductus arteriosus in preterm infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant born between 24 +0 and 32 +6 j GA
- •Ductus arteriosus surgery scheduled in Robert Debré hospital
- •Informed consent of the holders of the exercise of parental authority
- •Child beneficiary of a social security scheme (excluding AME)
排除标准
- •Obvious underlying disease (genetic, metabolic)
研究组 & 干预措施
Laser stimulation
Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment.
This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery)
干预措施: Laser stimulation (Device)
fake laser stimulation
newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage
干预措施: Fake laser stimulation (Device)
结局指标
主要结局
Behavioral pain scale (COMFORT scale)
时间窗: 48 hours post-operative
Behavioral pain scale (COMFORT scale) studied at a painful procedure (endotracheal suctioning, ETS) with a regular assessment in perioperative. All the ETS will videotaped with a color digital camera by the research assistant.
次要结局
- Behavioral pain scale (DAN scale and EDIN scale)(48hours postoperative)
- Consumption of morphine(48 hours postoperative)
- Measurement of FIO2(48 hours postoperative)