Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients
Information source: Saint Francis Care
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Pain
Intervention: Acetaminophen (Drug); Placebo (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Saint Francis Care Official(s) and/or principal investigator(s): Ioannis Raftopoulos, MD, Principal Investigator, Affiliation: Saint Francis
Summary
Bariatric patients usually require the use of either intravenous or oral opioid medications.
The use of opioids, however, is often associated with side-effects such as nausea, sedation
pruritus, urinary retention and respiratory depression with often delay patient discharge.
This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to
determine if this will decrease the use of opioids post-operatively for pain management in
morbidly obese patients undergoing laparoscopic bariatric surgery.
Clinical Details
Official title: Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Primary outcome: Pain relief measured at selected intervals
Secondary outcome: Comparison of Recovery room pain management dataComparison of patient satisfaction
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Morbidly Obese and body mass index (BMI) of 35
- Between ages 20-17
- Candidates for Laparoscopic Bariatric Surgery
Exclusion Criteria:
- know hypersensitivity to acetaminophen or opioids
- impairment in liver function
- renal dysfunction
- mental retardation
Locations and Contacts
Saint Francis Hospital, Hartford, Connecticut 06105, United States
Additional Information
Starting date: March 2012
Last updated: March 10, 2014
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