drugset / Trial / NCT04566250

Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin)

NCT04566250 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.

Timeline

Start
2021-02-24
Primary completion
2022-04-01
Completion
2022-04-01

Outcome

Met primary endpoint

paper Patients in the opioid-sparing protocol consumed significantly fewer opioids (median, 0 mg; IQR, 0-8.0 mg) than patients in the control group (median, 40.0 mg; IQR, 7.5-105.0; z = -6.55; P < .001). PMID 36194219 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Subject Hydromorphone Other / unclassified 1 mg Oral
Subject Naproxen Small molecule 500 mg Oral
Background Pantoprazole Other / unclassified 40 mg Oral

Indications

No indication recorded.