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Trial record 55 of 1879 for:    Acetaminophen

Efficacy of IV Acetaminophen for Pain Management

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ClinicalTrials.gov Identifier: NCT02028715
Recruitment Status : Completed
First Posted : January 7, 2014
Results First Posted : December 25, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Aultman Health Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Placebo Drug: IV acetaminophen Phase 4

Detailed Description:

This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:

  1. Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
  2. Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. 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. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: 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.
Actual Study Start Date : December 24, 2013
Actual Primary Completion Date : June 4, 2014
Actual Study Completion Date : June 4, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Experimental (Normal Saline)
Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Drug: Placebo
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.
Other Name: IV Placebo

Active Comparator: Experimental (IV Acetaminophen)
Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. 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. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Drug: IV acetaminophen
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.
Other Name: Ofirmev




Primary Outcome Measures :
  1. Opioid Rescue - 48 Hours [ Time Frame: First 48 hours including pre-operative and intra-operative medications ]
    Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine


Secondary Outcome Measures :
  1. Return of Bowel Function [ Time Frame: Duration of hospital stay (up to 7 days). ]
    Time to return of bowel function (passage of flatus) in hours

  2. Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge [ Time Frame: At 24 hours 48 hours, and discharge (up to 7 days) ]
    Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

  3. Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge [ Time Frame: At 24 hours, 48 Hours, and Discharge (up to 7 days) ]
    Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

  4. Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge [ Time Frame: At 24 hours, 48 Hours, and Discharge (up to 7 days) ]
    Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

  5. Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge [ Time Frame: At 24 hours, 48 Hours, and Discharge (up to 7 days) ]
    Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

  6. Length of Stay [ Time Frame: Surgery to discharge ]
    Mean length of post-operative stay in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

Exclusion Criteria:

  • Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
  • Patients with baseline CrCl <30.
  • Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
  • Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
  • Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
  • Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
  • Patients that have required regular opioid intake for the 7 days preceding surgery.
  • NSAIDs within 8 hours of surgery.
  • Chronic steroid use with the exception of low-dose inhaled steroid formulations.
  • Chronic alcohol or drug abuse.
  • Patients currently pregnant.
  • Patients unable to provide informed consent.
  • Age >85
  • Any physical, medical, and mental condition that would make participation in the study inadvisable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028715


Locations
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United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44720
Sponsors and Collaborators
Aultman Health Foundation
Investigators
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Principal Investigator: Laura K Randolph, DO, MS Aultman Health Foundation

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Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT02028715     History of Changes
Other Study ID Numbers: 2013.08.22.F2
First Posted: January 7, 2014    Key Record Dates
Results First Posted: December 25, 2018
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Aultman Health Foundation:
IV Acetaminophen
Ofirmev
Post-operative pain
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics