Acetominophen
DrugINTRAVENOUS
Other names: Ofirmev
NCT Number: NCT03391284
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Primary outcome:
• Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
* Difference in postoperative analgesic use between groups
o Narcotics, NSAIDs * Difference in postoperative N/V between groups
o Patient rated measure - none, mild, moderate, severe * Cost comparison between drugs
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Notify Me18 year and older
Female
Interventional
Not applicable
Scripps Clinic, San Diego, California, United States
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.
Primary outcome:
Secondary outcomes:
Methods:
Patients scheduled to undergo minimally invasive benign gynecologic surgery will be randomized to one of two groups:
Group 1: acetaminophen 1 gram PO 30min before surgery, then saline placebo IV after anesthesia induction but before skin incision
Group 2: receives placebo pill PO 30min before surgery, then acetaminophen 1 gram IV after anesthesia induction but before skin incision
Primary outcome: After surgery, postoperative pain measured at various time points by blinded investigator
2 hours postop, 4 hours postop, 24 hours postop
Secondary outcomes:
Demographics to collect:
Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
INTRAVENOUS
Other names: Ofirmev
ORAL
Other names: Tylenol
Time frame: 2 hours
Pain level 2 hours post treatment
Time frame: 4 hours
Pain level 4 hours post treatment
Time frame: 24 hours
Pain level 24 hours post treatment
Scripps Health
Other
Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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