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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04246541
Other study ID # STUDY20181100
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 23, 2019
Est. completion date September 12, 2021

Study information

Verified date March 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 12, 2021
Est. primary completion date September 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Patients between 18 and 89 years of age - Patients undergoing primary arthroscopic meniscus surgery Exclusion Criteria: - Patients age less than 18 or greater than 89 years - Illiterate or non-English speaking patients - Patients with contraindications to ketorolac - History of drug or alcohol abuse - Chronic use of analgesic or psychotropic drugs

Study Design


Intervention

Drug:
Ketorolac
Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Oxycodone-Acetaminophen
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.

Locations

Country Name City State
United States UH Cleveland Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Levels Recorded With a Visual Analogue Scale Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. 2 weeks postoperatively
Primary Narcotic Medication Consumed Number of oxycodone- acetaminophen tablets consumed up to 5 days postoperatively
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