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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-16 days following surgery discharge
Awards & highlights

PROTECT Trial 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.Check my eligibility
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.See study design
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.

PROTECT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Opioid disposal

PROTECT 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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,808 Previous Clinical Trials
6,384,516 Total Patients Enrolled
2 Trials studying Acute Pain
60 Patients Enrolled for Acute Pain
Mark Bicket, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
499 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
Mark Bicket, MD, PhD 2022. "Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370404.
All > Acute Pain
~50 spots leftby Nov 2024
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