NCT01798316

IV Acetaminophen for Postoperative Analgesia

IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 management decreases the incidence of post-operative nausea and vomiting.

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 suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Conditions

• Postoperative Pain
• Postoperative Nausea
• Postoperative Vomiting

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
DRUG	Standard of Care	Standard of care pain management regimen, no IV Acetaminophen,

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-02-25
• Last updated: 2017-05-31
• Results posted: 2017-05-31

Locations

3 sites across 1 country: United States