Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain:

University of Michigan

Status: Completed

Conditions: Surgery; Acute Pain

Treatments: Other: Recommendation by surgical team; Other: Prescription by surgical team

Study type: Interventional

Funder types: Other

Identifiers

NCT05370404

HUM00203454

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Prescription Group for acetaminophen, NSAIDs, and magnesium

Active Comparator group

Description:

Participants will receive prescriptions from the surgical team for non-opioid pain medications to take at home after discharge from surgery. The non-opioid pain medications will be acetaminophen 1000 milligram (mg) four times a day (qid) for 3 days then as needed (prn) pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain.

Treatment:

Other: Prescription by surgical team

Over the Counter Group

Active Comparator group

Description:

Participants will receive a recommendation from the surgical team to take over-the-counter non-opioid pain medications at home after discharge from surgery. The non-opioid pain medications will be acetaminophen 1000 mg qid for 3 days then prn pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain.

Treatment:

Other: Recommendation by surgical team