Saint Louis, Missouri 63104


Purpose:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


NCT ID:

NCT03677830


Primary Contact:

Marya Strand, MD, MS
Phone: 3145775642
Email: marya.strand@health.slu.edu


Backup Contact:

Email: gustavo.villalona@health.slu.edu
Gustavo Villalona, MD
Phone: 3145775629


Location Contact:

Saint Louis, Missouri 63104
United States

JoAnn Filla-Taylor, BSN, RN
Phone: 314-977-7525
Email: joann.fillataylor@health.slu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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