Meniscectomy
Conditions
Keywords
Knee Arthroscopy
Brief summary
Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.
Detailed description
Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.
Interventions
DRUGKetorolac Dose
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators. Inclusion Criteria: 1. Ability to consent and desire to participate in study 2. Outpatient knee arthroscopy with Dr. C. David Geier 3. ASA physical status I-III 4. 18-65 years old 5. Over 50 kg (110 pounds) 6. General anesthesia
Exclusion criteria
1. Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding) 2. Allergy to propofol, fentanyl or hydromorphone. 3. Any chronic painful conditions requiring opioid use for over the last 6 months 4. Emergency surgery 5. Altered mental status (not oriented to place, person or time) 6. Pregnant or lactating patients 7. Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery. 8. Non-English speaking 9. Patient refusal to study 10. Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PACU Opiate Consumption | Less than 1 day (PACU stay in the postoperative period) | Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0 mg of Ketorolac participant receives 0 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 28 |
| 7.5 mg of Ketorolac participant receives 7.5 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 28 |
| 15 mg Ketorolac participant receives 15 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 28 |
| 30 mg Ketorolac participant receives 30mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 28 |
| Total | 112 |
Baseline characteristics
| Characteristic | 7.5 mg of Ketorolac | 15 mg Ketorolac | 0 mg of Ketorolac | 30 mg Ketorolac | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 28 Participants | 28 Participants | 28 Participants | 112 Participants |
| Age, Continuous | 44.2 Years STANDARD_DEVIATION 12.7 | 44.7 Years STANDARD_DEVIATION 14.2 | 49.4 Years STANDARD_DEVIATION 11.9 | 44.4 Years STANDARD_DEVIATION 13 | 45.7 Years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 28 Participants | 28 Participants | 28 Participants | 28 Participants | 112 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 14 Participants | 12 Participants | 49 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 14 Participants | 16 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 28 |
Outcome results
Primary
PACU Opiate Consumption
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Time frame: Less than 1 day (PACU stay in the postoperative period)
Population: The study enrolled 112 patient with 28 patients randomized to each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg of Ketorolac | PACU Opiate Consumption | 7.7 IV Morphine Equivalents (mg) | Standard Error 0.86 |
| 7.5 mg of Ketorolac | PACU Opiate Consumption | 6.3 IV Morphine Equivalents (mg) | Standard Error 0.86 |
| 15 mg Ketorolac | PACU Opiate Consumption | 6.5 IV Morphine Equivalents (mg) | Standard Error 0.86 |
| 30 mg Ketorolac | PACU Opiate Consumption | 5.0 IV Morphine Equivalents (mg) | Standard Error 0.86 |