drugset / Trial / NCT03677830

Postoperative Pain Control & Relief in Neonates

NCT03677830 ↗

Phase 4 Terminated 11 enrolled St. Louis University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-04-19
Primary completion
2024-03-07
Completion
2024-03-07

Outcome

Outcome not reported

Stopped: “Involved investigators no longer at the investigating center”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 10 mg/kg Intravenous

Indications