Postoperative Pain Control & Relief in Neonates
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/5/2019 |
| Start Date: | April 25, 2019 |
| End Date: | April 1, 2022 |
| Contact: | Marya Strand, MD, MS |
| Email: | marya.strand@health.slu.edu |
| Phone: | 3145775642 |
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.
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.
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
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