Status:
TERMINATED
IV Acetaminophen for Postoperative Analgesia
Lead Sponsor:
Northwell Health
Conditions:
Postoperative Pain
Postoperative Nausea
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ma...
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 suit...
Eligibility Criteria
Inclusion
- Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- American Society of Anesthesiology patient classification status I-II
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01798316
Start Date
March 1 2013
End Date
September 1 2015
Last Update
May 31 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
North Shore University Hospital
Manhasset, New York, United States, 11030
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
3
Syosset Hospital
Syosset, New York, United States, 11791