CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
IV Acetaminophen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02069184
NCT02069184Phase 4Completed

Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Montefiore Medical Center·interventional·Posted Feb 24, 2014·Updated Aug 22, 2019

In Brief

A Phase 4 clinical trial evaluating IV Acetaminophen and Saline as placebo for Post-operative Pain. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2014
Enrollment StartNov 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago

Interventions

IV Acetaminophendrug

1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly

Saline as placeboother

100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.