Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction, Opioid Use
Conditions
Keywords
ketorolac, meniscus tear, analgesics, pain
Brief 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.
Interventions
DRUGKetorolac
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.
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels Recorded With a Visual Analogue Scale | 2 weeks postoperatively | 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. |
| Narcotic Medication Consumed | up to 5 days postoperatively | Number of oxycodone- acetaminophen tablets consumed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery
Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. | 25 |
| Ketorolac Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.
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. | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | Ketorolac | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 48 Participants | 25 Participants |
| Age, Continuous | 47.9 years STANDARD_DEVIATION 13.1 | 47.9 years STANDARD_DEVIATION 14.3 | 47.9 years STANDARD_DEVIATION 15.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 48 Participants | 25 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 23 participants | 48 participants | 25 participants |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Narcotic Medication Consumed
Number of oxycodone- acetaminophen tablets consumed
Time frame: up to 5 days postoperatively
Population: 9 subjects, including 4 in the control group and 5 in the ketorolac group, failed to report complete data on postoperative number of oxycodone-acetaminophen tablets consumed and were therefore excluded from data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Narcotic Medication Consumed | 5.7 tablets | Standard Deviation 7.2 |
| Ketorolac | Narcotic Medication Consumed | 3.5 tablets | Standard Deviation 3.7 |
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.
Time frame: 2 weeks postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain Levels Recorded With a Visual Analogue Scale | 25.6 score on a scale | Standard Deviation 22.7 |
| Ketorolac | Pain Levels Recorded With a Visual Analogue Scale | 28.8 score on a scale | Standard Deviation 26.3 |