Clinical trial NCT03677830: Postoperative Pain Control & Relief in Neonates
Official title: Postoperative Pain Control & Relief in Neonates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Premature Infant
Opioid Use
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 11
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Total morphine exposure
timeFrame: 72 hours following surgical procedure
Secondary outcomes:
measure: Total "as needed" morphine exposure
timeFrame: 72 hours following surgical procedure
Other outcomes:
measure: Apnea of >20 seconds
timeFrame: 72 hours following surgical procedure
measure: Time to first feed
timeFrame: up to 2 weeks
measure: Time to full enteral feeds
timeFrame: up to 8 weeks
measure: Time to endotracheal extubation
timeFrame: up to 2 weeks
measure: Incidence of opiate withdrawal symptoms
timeFrame: up to 8 weeks
Locations:
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
Study officials:
References: