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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Postoperative Nausea Postoperative Vomiting||Drug: IV Acetaminophen Drug: Standard of Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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.
- 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
- 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
- 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
- Narcotic Use During PACU Stay [ Time Frame: 4 hours plus/minus 30 minutes ]Narcotic medication administered during PACU stay in morphine milligram equivalents
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
|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, New York, United States, 11791|
|Principal Investigator:||Frank J Overdyk, MD||Northwell Health|