Opioid Use, Pain, Postoperative, Premature Infant
Conditions
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.
Interventions
DRUGAcetaminophen
Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
DRUGSaline
Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The intervention (intravenous acetaminophen) and placebo (saline) will be distributed by the pharmacy and are visually indistinguishable.
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine exposure | 72 hours following surgical procedure | Total amount of morphine received by infants for pain control post-operatively in mg/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total as needed morphine exposure | 72 hours following surgical procedure | Total as needed or prn doses of morphine received by infants for pain control post-operatively in mg/kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to full enteral feeds | up to 8 weeks | Number of hours/days until receiving all nutritional support enterally following surgical procedure |
| Apnea of >20 seconds | 72 hours following surgical procedure | Apnea episodes of \>20 seconds documented by nursing staff after surgical procedure |
| Incidence of opiate withdrawal symptoms | up to 8 weeks | Number of infants that develop withdrawal symptoms from opiate exposure |
| Time to endotracheal extubation | up to 2 weeks | Number of hours from surgical procedure to endotracheal extubation |
| Time to first feed | up to 2 weeks | Number of hours to first enteral feeding after surgical procedure |
Countries
United States
Outcome results
None listed