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Postoperative Pain Control & Relief in Neonates

NCT03677830 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-03-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2024-03-07
Completion
2024-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677830 on ClinicalTrials.gov