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

NCT05370404 | Completed

• 1 other identifier: HUM00203454
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Surgery

Keywords

Medications after surgery; Surveys; Acetaminophen; NSAIDS; Opioids; Elective outpatient surgery; Magnesium

Outcome Measures

Primary Outcomes (5)

• Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery

  Patient report of the number of doses within the first 3 days of the use of both acetaminophen and NSAID at home after discharge from surgery. Patients are anticipated to take up to 4 doses of acetaminophen and NSAIDs per day. Over 3 days, patients would be anticipated to take a maximum of 12 doses. This outcome is a count that ranges from 0 (no doses of acetaminophen plus NSAIDs) to 12.

  3 days following surgery discharge

• Patient use of acetaminophen within 3 days after discharge from surgery

  Patient-reported use of acetaminophen at any point in time within the first 3 days at home after discharge from surgery.

  3 days following surgery discharge

• Patient use of NSAIDS within 3 days after discharge from surgery

  Patient-reported use of NSAIDs at any point in time within the first 3 days at home after discharge from surgery.

  3 days following surgery discharge

• Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery

  Patient-reported use of both acetaminophen and NSAID on every day oral pain medication is taken within the first 3 days at home after discharge from surgery.

  3 days following surgery discharge

• Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery

  Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery.

  12-16 days following surgery discharge

Secondary Outcomes (8)

• Patient-reported consumption of opioid pills within 3 days after discharge from surgery

  3 days following surgery discharge

• Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery

  12-16 days following surgery discharge

• Pain intensity at site of surgery 3 days following surgery discharge

  3 days following surgery discharge

• Pain intensity at site of surgery as reported at 12-16 days following surgery discharge

  3 days following surgery discharge

• Medication side effects within 3 days following surgery discharge

  3 days following surgery discharge

Other Outcomes (1)

• Opioid disposal

  3-16 days following surgery discharge

Study Arms (2)

Prescription Group for acetaminophen, NSAIDs, and magnesium

ACTIVE COMPARATOR

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.

Other: Prescription by surgical team

Over the Counter Group

ACTIVE COMPARATOR

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.

Other: Recommendation by surgical team

Interventions

Prescription by surgical team OTHER

The surgical team prescribes medications to the patient

Prescription Group for acetaminophen, NSAIDs, and magnesium

Recommendation by surgical team OTHER

The surgical team recommends the patient to take over-the-counter medications

Over the Counter Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Bicket, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: September 30, 2022
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)