A Randomized, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects
Abstract
Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this.
The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics (PK)\].
Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.
This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers.
IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.
Conditions: Pain.
Primary outcome: Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen; Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration; Maximum Concentration (Cmax) of Acetaminophen; Time to Maximum Concentration (Tmax) of Acetaminophen.
Enrollment: 50 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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