Postoperative Pain Control & Relief in Neonates

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pain, Postoperative, Premature Infant, Opioid Use

In brief

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.

Key facts

Study ID

NCT03677830

Run by

St. Louis University

People needed

11

Starts

2019-04-19

Expected to finish

2024-03-07

Last updated by the study team

2024-03-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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