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Prescription vs OTC Analgesics for Postoperative Pain (PROTECT Trial)

N/A

Recruiting

Led By Mark Bicket, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Contraindications to taking acetaminophen or NSAIDs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-16 days following surgery discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether getting prescriptions for pain meds is better than taking them OTC.

Who is the study for?

This trial is for individuals expected to use opioid medication for acute pain after elective outpatient surgery. They must be able to receive emails or phone calls for follow-up. People with contraindications to acetaminophen or NSAIDs, pre-surgery analgesic use, or complications within 14 days post-surgery cannot join.

What is being tested?

The study compares two approaches: one group will get prescriptions for acetaminophen, NSAIDs, and magnesium from their surgical team; the other will be advised to take these medications over-the-counter in identical dosages.

What are the potential side effects?

Potential side effects include those commonly associated with acetaminophen and NSAIDs such as stomach upset, bleeding risks, kidney problems, liver damage (rare), and allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take acetaminophen or NSAIDs due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-16 days following surgery discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-16 days following surgery discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-16 days following surgery discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Patient use of NSAIDS within 3 days after discharge from surgery

+2 more

Secondary study objectives

Delayed magnesium use days as reported at 12-16 days after discharge from surgery

Medication side effects within 3 days following surgery discharge

Pain intensity at site of surgery 3 days following surgery discharge

+5 more

Other study objectives

Opioid disposal

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Prescription Group for acetaminophen, NSAIDs, and magnesiumActive Control1 Intervention

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.

Group II: Over the Counter GroupActive Control1 Intervention

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.

0 / 1Eligibility criteria met