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NCT02028715 · ClinicalTrials.gov registry record · Phase 4

Efficacy of IV Acetaminophen for Pain Management

A Phase 4 study of Post Operative Pain, sponsored by Aultman Health Foundation.

Completed
Registry status
Phase 4
Development phase
68
Enrollment target
1
Study location

NCT02028715 is a Phase 4 study of Post Operative Pain that has completed, run by Aultman Health Foundation. The registered enrollment target is 68 participants, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02028715, a Phase 4 study of Post Operative Pain, has completed, sponsored by Aultman Health Foundation.

COMPLETED
Registry status
Phase 4
Development phase
68 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG IV acetaminophen

Study Locations (1)

Ohio

  • Aultman Health Foundation - Canton

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2013-12-24
Est. Completion 2014-06-04
Phase Phase 4

Sponsor

Aultman Health Foundation

12 total trials

What the Registry Record Tells You About NCT02028715

The ClinicalTrials.gov registry entry for NCT02028715 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (71% lower). The listed sponsor is Aultman Health Foundation, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02028715 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT02028715 about?

NCT02028715 is a clinical study titled "Efficacy of IV Acetaminophen for Pain Management". 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 ...

What is the current status of trial NCT02028715?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2013-12-24. Estimated completion is 2014-06-04.

What conditions does trial NCT02028715 study?

This clinical trial studies the following conditions: Post Operative Pain.

What interventions are being tested in trial NCT02028715?

The interventions under investigation include: Placebo (DRUG), IV acetaminophen (DRUG).

Who is sponsoring clinical trial NCT02028715?

This trial is sponsored by Aultman Health Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02028715 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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