Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The PIPP-Score, a validated pain-score, is used to measure the patient's pain
研究概览
简要总结
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).
In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks
- •CPAP respiratory therapy
- •Parents' given written consent
排除标准
- •Diseases complicating neuromuscular evaluation.
- •Drug abuse by the mother
- •Administration of other analgetic or sedative drugs within the previous 48h.
- •Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
研究组 & 干预措施
Glucose 20%
干预措施: Glucose 20% (Drug)
placebo
干预措施: Aqua (Drug)
结局指标
主要结局
The PIPP-Score, a validated pain-score, is used to measure the patient's pain
时间窗: during nasopharyngeal suctioning
次要结局
未报告次要终点