CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
IV acetaminophen 1,000mgfrom 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/NCT02028715
NCT02028715Phase 4Completed

Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay.

Aultman Health Foundation·interventional·Posted Jan 7, 2014·Updated Jan 16, 2019

In Brief

A Phase 4 clinical trial evaluating Placebo and IV acetaminophen for Post-operative Pain. Completed, enrolled 68 participants across 1 site.

Detailed Summary

The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 7, 2014
Enrollment StartDec 24, 2013
Primary CompletionJun 4, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.5 years ago

Interventions

Placebodrug

Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

IV acetaminophendrug

IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.