A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures (Cadence)
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Details and patient eligibility
About
This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.
Full description
Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
Sex
Ages
Volunteers
Inclusion criteria
- Undergoing ambulatory surgery under general anesthesia
- Expected postoperative pain to be mild-moderate
- Age 18 years or older
- Have an ASA physical status or 1, 2, or 3
Exclusion criteria
- Anticipated peripheral or neuraxial nerve block
- Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
- Current chronic opioid or tramadol use
- History of alcohol or opioid abuse
- Known allergy to the study medications
- Pregnancy
- Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
- Treated with any acetaminophen-containing medication in the previous 8 hours
- Treated with MAO inhibitors within 10 days prior to surgery
- Inability to communicate with the investigators and hospital staff
- Known or impaired liver function
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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