Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy (IVTYLENOL)
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|ClinicalTrials.gov Identifier: NCT02025634|
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Intravenous Acetaminophen Drug: Placebo (0.9% Normal Saline infusion)||Phase 4|
This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).
The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Intravenous acetaminophen
Infusion of Intravenous acetaminophen (Ofirmev)
Drug: Intravenous Acetaminophen
Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
Other Name: Ofirmev
Placebo Comparator: Placebo (0.9% Normal Saline Infusion)
Infusion of 100 ml of 0.9 NS Normal Saline
Drug: Placebo (0.9% Normal Saline infusion)
Infusion of 100 ml of 0.9% NS
Other Name: NS
- Postoperative pain levels [ Time Frame: up to 8 hours ]To determine if postoperative pain levels, as measured by a VNRS, are reduced with the administration of IV acetaminophen when compared to a control group
- Postoperative opioid consumption [ Time Frame: up to 8 hours ]To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.
- Total time in PACU [ Time Frame: up to 8 hours ]To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.
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): NCT02025634
|United States, Florida|
|Florida Hospital Celebration Health|
|Celebration, Florida, United States, 34747|
|Principal Investigator:||Bradley Homan, DO||Florida Hospital Celebration Health|