NCT03677830

Postoperative Pain Control & Relief in Neonates

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative
• Premature Infant
• Opioid Use

Interventions

Type	Name	Description
DRUG	Acetaminophen	Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
DRUG	Saline	Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Timeline

• Start date: 2019-04-19
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2018-09-19
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study