Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients
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|ClinicalTrials.gov Identifier: NCT01527942|
Recruitment Status : Terminated (Study Terminated per Principal Investigator's request)
First Posted : February 7, 2012
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pain||Drug: Acetaminophen Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Arm 1 - Active Drug
Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Intravenous Acetaminophen 1,000 mg IV
Other Name: OFIRMEV
Placebo Comparator: Arm 2 - Placebo
Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)
- Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ]The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)
- Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ]The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)
- Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. [ Time Frame: 24 hours after baseline ]The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.
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): NCT01527942
|United States, Connecticut|
|Saint Francis Hospital|
|Hartford, Connecticut, United States, 06105|
|Principal Investigator:||Ioannis Raftopoulos, MD||Saint Francis|