Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Premature Infant Pain (PIPP) Scale
研究概览
简要总结
The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants
详细描述
Preterm infants admitted to NICUs are exposed to a range of painful procedures. The exposure to pain during this critical of brain development may have adverse consequences. Application of nasal CPAP is one of the painful procedures. A consensus statement on neonatal pain made recommendations for analgesia for neonatal procedures. Topical lidocaine is frequently used as a topical anesthetic during venipuncture, heel lancing, circumcision, endotracheal intubations, nasogastric tube insertion, endoscopy and bronchoscopy. However, the use of topical lidocaine for its analgesic effect on application of nasal CPAP has not been evaluated.
This study proposes a randomized controlled trial to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants < 37 weeks gestation
- •Admitted to NICU, Mansoura University Children's Hospital
- •Respiratory distress requiring use of nasal CPAP
- •Informed consent obtained
排除标准
- •Serious, life-threatening malformations
- •Use of sedation, analgesia in the preceding 72 hours
- •Those who undergo any surgical intervention
- •Those who undergo any painful procedures as venipuncture, intubation, suctioning, blood sampling, heel-prick, catheterization 30 minutes before assessment
- •Those with signs of nasal injuries at the time of application of nCPAP
- •Necrotizing enterocolitis
研究组 & 干预措施
Lidocaine
Intervention: Topical lidocaine gel 2% (0.3 ml/kg) will be applied once only to the nostrils and nasal CPAP prong 5 minutes prior to the application of nasal CPAP
干预措施: Lidocaine 2% Gel (Drug)
结局指标
主要结局
The Premature Infant Pain (PIPP) Scale
时间窗: Immediately after application of nasal CPAP (approx 5 min)
PIPP comprises 3 behavioral variables (time of brow bulge, eye squeeze, and naso-labial furrow), 2 physiologic variables (changes in heart rate and SpO2), and 2 contextual variables (gestational age and behavioral state). Behavioral state ranges from "active/awake, eyes open, facial movements" to "quiet/sleep, eyes closed, no facial movements." Every variable will be scored on a scale from 0 to 3. A total score the sum of total of points indicating: lack of pain (0-6), mild -moderate pain (6-12) and severe pain (above 12). PIPP has documented reliability and validity and have been used previously in several studies in neonates. PIPP score measurement will be based on video recording the infant for 45 seconds. Three different DVDs will be compiled with the sets in random order. Three different nurses from NICU will be recruited to evaluate the segments. They will not be informed of the nature of the study. All 3 nurses are trained in performing the PIPP.
次要结局
- Possible adverse effects to lidocaine(Within 72 hours of application of topical lidocaine gel)
- Nasal trauma(24 hours after application of nasal CPAP)
- Salivary cortisol(30 minute after application of nasal CPAP)
- Duration of first cry(Immediately after application of nasal CPAP (approx 5 min))
研究者
Hesham Abdel-Hady
Professor of Pediatrics
Mansoura University Children Hospital