Intravenous Acetaminophen for Pain, Postoperative

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Pain, Postoperative+2 More
Acetaminophen - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether adding acetaminophen to standard narcotic pain control reduces narcotic use and adverse effects in newborns.

Eligible Conditions
  • Pain, Postoperative
  • Opioids Use
  • Infants, Premature

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 72 hours following surgical procedure

Hour 72
Apnea of >20 seconds
Total "as needed" morphine exposure
Total morphine exposure
up to 2 weeks
Time to endotracheal extubation
Time to first feed
up to 8 weeks
Incidence of opiate withdrawal symptoms
Time to full enteral feeds

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Intravenous Acetaminophen
1 of 2
Intravenous Placebo
1 of 2
Active Control
Non-Treatment Group

11 Total Participants · 2 Treatment Groups

Primary Treatment: Intravenous Acetaminophen · Has Placebo Group · Phase 4

Intravenous Acetaminophen
Drug
ActiveComparator Group · 1 Intervention: Acetaminophen · Intervention Types: Drug
Intravenous Placebo
Drug
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours following surgical procedure

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
183 Previous Clinical Trials
37,409 Total Patients Enrolled
3 Trials studying Pain, Postoperative
322 Patients Enrolled for Pain, Postoperative

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.