Postoperative Pain Control & Relief in Neonates
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Total morphine exposure
研究概览
简要总结
Pain control for newborns has made significant improvements over the last 30 years. The use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. Narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and withdrawal symptoms. Acetaminophen (Tylenol©) has been proposed as an adjunct to reduce narcotic use but current evidence from well designed studies in newborns and premature infants is limited. This study will randomly assign neonates undergoing a surgery to either morphine plus acetaminophen or morphine alone for pain control. The subjects will be followed for 72 hours after the operation and evaluate the benefits of acetaminophen for pain control.
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)
盲法说明
The intervention (intravenous acetaminophen) and placebo (saline) will be distributed by the pharmacy and are visually indistinguishable.
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All neonates ≥ 28 weeks of gestation and <44 weeks of gestation undergoing general surgery procedures (below) and managed postoperatively in the Neonatal Intensive Care Unit (NICU).
- •Minor procedures Inguinal hernia repair Laparoscopic or open gastrostomy tube placement Peritoneal drain placement for spontaneous intestinal perforation Gastroschisis bedside patch closure
- •Major procedures Laparoscopic or open Nissen fundoplication, duodenal atresia repair, Hirschsprung pull through, Ladd's procedure or excision of abdominal cyst Thoracoscopy or thoracotomy procedure Enterostomy or colostomy creation Exploratory laparotomy Revision or closure of enterostomy or colostomy Any Gastroschisis or omphalocele repair in operating room Repair or staged repair of congenital anorectal malformations Resection of sacrococcygeal teratoma
排除标准
- •Any infant admitted with preoperative diagnosis of neonatal abstinence syndrome (NAS) or known intrauterine opiate exposure
- •Any diagnosis of hepatitis exclusive of TPN-related biliary cholestasis
- •Renal disease with creatinine >2.0 mg/dl at enrollment
- •Intraventricular hemorrhage grade 3 or greater, or cerebellar hemorrhage
- •Any patient with myotonic dystrophy or other congenital disease limiting validity of pain scoring
- •Opiate exposure within 14 days of operative procedure
- •Non-English-speaking parents/guardians
研究组 & 干预措施
Intravenous Acetaminophen
Infants randomized to the intervention arm will receive scheduled IV acetaminophen per LexiComp dosing guideline (28 0/7-32 6/7 weeks 10 mg/kg/dose every 12 hours; 33 0/7-38 6/7 weeks 10 mg/kg/dose every 8 hours; >39 0/7 weeks 10 mg/kg/dose every 6 hours). N-PASS scores will guide administration of IV morphine. Continuous infusion of morphine will be started if an infant requires 3 doses of morphine within a 6-hour period and titrated as needed per N-PASS scores.
干预措施: Acetaminophen (Drug)
Intravenous Placebo
Infants randomized to the control arm will receive normal saline placebo IV at the appropriate volume and times for the gestational age. IV acetaminophen is concentrated at 10 mg/ml; corresponding saline volumes will be 1 ml to 5 ml, approximately, based on subject weight. Control infants will also have N-PASS scores assessed using the same protocol following the surgical procedure for 72 hours. Dosing of IV morphine will be the same as the dosing for the intervention arm.
干预措施: Saline (Drug)
结局指标
主要结局
Total morphine exposure
时间窗: 72 hours following surgical procedure
Total amount of morphine received by infants for pain control post-operatively in mg/kg
次要结局
- Total "as needed" morphine exposure(72 hours following surgical procedure)
研究者
Marya Strand, MD
Associate Professor of Pediatrics
St. Louis University