Clinical trial NCT05370404: Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain:
Official title: Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain: a Project on Non-Opioid Pain Medication Use After Discharge from Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Surgery
Keywords: Medications after surgery
Surveys
Acetaminophen
NSAIDS
Opioids
Elective outpatient surgery
Magnesium
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a research project in which two standard of care practices will be evaluated to examine the difference in outcomes. The goal is to improve patient care and safety. One group will receive prescriptions for acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and magnesium. The other group will receive the recommendation to take acetaminophen, NSAIDs, and magnesium as over-the-counter drugs in the same dosage as the prescription group. The same doses and routes for non-opioid medications will be used in both groups.


Eligibility criteria: Inclusion Criteria:

* Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery

Exclusion Criteria:

* Contraindications to taking acetaminophen or NSAIDs
* Significant analgesic medication use before surgery
* Inability to receive emails or phone calls for follow up assessment
* Patients who have reoperation, another surgery, or experience complications within 14 days after surgery

Primary outcomes:
measure: Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Patient use of acetaminophen within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Patient use of NSAIDS within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery
timeFrame: 12-16 days following surgery discharge
Secondary outcomes:
measure: Patient-reported consumption of opioid pills within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery
timeFrame: 12-16 days following surgery discharge
measure: Pain intensity at site of surgery 3 days following surgery discharge
timeFrame: 3 days following surgery discharge
measure: Pain intensity at site of surgery as reported at 12-16 days following surgery discharge
timeFrame: 3 days following surgery discharge
measure: Medication side effects within 3 days following surgery discharge
timeFrame: 3 days following surgery discharge
measure: Patient satisfaction with pain treatment within 3 days following surgery discharge
timeFrame: 3 days following surgery discharge
measure: Patient use of magnesium within 3 days after discharge from surgery
timeFrame: 3 days following surgery discharge
measure: Delayed magnesium use days as reported at 12-16 days after discharge from surgery
timeFrame: 12-16 days following surgery discharge
Other outcomes:
measure: Opioid disposal
timeFrame: 3-16 days following surgery discharge
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Bicket, MD
role: PRINCIPAL_INVESTIGATOR
References: