Postoperative Pain Control & Relief in Neonates

Phase 4TerminatedNCT03677830

St. Louis University11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative Premature Infant Opioid Use

Interventions

AcetaminophenDRUG

Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.

SalineDRUG

Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Eligibility

Sex: ALLMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total morphine exposure

Total amount of morphine received by infants for pain control post-operatively in mg/kg

Time frame: 72 hours following surgical procedure

Secondary Outcomes

Total "as needed" morphine exposure

Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg