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Trial record 65 of 1877 for:    ACETAMINOPHEN

IV Acetaminophen for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT01798316
Recruitment Status : Terminated (Principal Investigator left the institution)
First Posted : February 25, 2013
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea Postoperative Vomiting Drug: IV Acetaminophen Drug: Standard of Care Phase 4

Detailed Description:
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
Study Start Date : March 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IV Acetaminophen
IV Acetaminophen administered on admission to post-anesthesia care unit
Drug: IV Acetaminophen
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
Other Name: Ofirmev

Active Comparator: Standard of care
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
Drug: Standard of Care
Standard of care pain management regimen, no IV Acetaminophen,
Other Name: As per provider: Opioids




Primary Outcome Measures :
  1. Number of Participants With Postoperative Nausea and Vomiting (PONV). [ Time Frame: 4 hours plus/minus 30 minutes ]

    Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.

    PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.



Secondary Outcome Measures :
  1. Number of Participants With Post Discharge Nausea and Vomiting (PDNV) [ Time Frame: Up to two days following surgery ]

    Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.

    PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.


  2. Highest Pain Intensity Score Using Numeric Rating Scale (NRS) [ Time Frame: 4 hours plus/minus 30 minutes ]
    Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.

  3. Patient Satisfaction on a 5 Point Likert Scale [ Time Frame: Up to one week following surgery ]
    Number of patients very satisfied or satisfied with pain and PONV management during hospital stay

  4. Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale [ Time Frame: 1 hour following surgery ]
    Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities


Other Outcome Measures:
  1. Number of Patients Requiring Rescue Analgesia for Breakthrough Pain [ Time Frame: 1 hour following surgery ]
    Number of patients requiring rescue analgesia medication during first hour of PACU stay

  2. Narcotic Use During PACU Stay [ Time Frame: 4 hours plus/minus 30 minutes ]
    Narcotic medication administered during PACU stay in morphine milligram equivalents



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
  • American Society of Anesthesiology patient classification status I-II

Exclusion Criteria:

  • Regular preoperative use of or opioids,
  • Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
  • Subjects converted to open laparoscopic cholecystectomy
  • Known allergy/hypersensitivity to acetaminophen
  • Use of opioids prior to commencement of the study (<7 days)
  • Patients with chronic pain conditions or disease requiring pain control
  • Abnormal liver function
  • Known or suspected alcohol, drug or opiate abuse or dependence
  • Patients with a BMI of greater than 35
  • Other physical, mental or medical conditions that could effect participation.
  • Abnormal renal function; serum creatinine>2gm/dl

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): NCT01798316


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Syosset Hospital
Syosset, New York, United States, 11791
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Frank J Overdyk, MD Northwell Health

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01798316     History of Changes
Other Study ID Numbers: 12-0409
IRB #12-409B ( Other Identifier: North Shore-Long Island Jewish Health System )
First Posted: February 25, 2013    Key Record Dates
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Northwell Health:
IV Acetaminophen
Laparoscopic cholecystectomy
Postoperative nausea
Postoperative vomiting
Additional relevant MeSH terms:
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Acetaminophen
Nausea
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics