Dose Response of Ketorolac in Knee Arthroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

Conditions
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Meniscectomy

Intervention / Treatment
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* Drug: Ketorolac Dose


Participation Criteria
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Eligibility Criteria
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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: Ability to consent and desire to participate in study Outpatient knee arthroscopy with Dr. C. David Geier ASA physical status I-III 18-65 years old Over 50 kg (110 pounds) General anesthesia Exclusion Criteria 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) Allergy to propofol, fentanyl or hydromorphone. Any chronic painful conditions requiring opioid use for over the last 6 months Emergency surgery Altered mental status (not oriented to place, person or time) Pregnant or lactating patients Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery. Non-English speaking Patient refusal to study Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 mg of Ketorolac<br>participant receives 0 mg of Ketorolac | Drug: Ketorolac Dose<br>* 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).<br>* Other names: Toradol;|
| Active Comparator: 7.5 mg of Ketorolac<br>participant receives 7.5 mg of Ketorolac | Drug: Ketorolac Dose<br>* 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).<br>* Other names: Toradol;|
| Active Comparator: 15 mg Ketorolac<br>participant receives 15 mg of Ketorolac | Drug: Ketorolac Dose<br>* 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).<br>* Other names: Toradol;|
| Active Comparator: 30 mg Ketorolac<br>participant receives 30mg of Ketorolac | Drug: Ketorolac Dose<br>* 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).<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU Opiate Consumption | Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME). | Less than 1 day (PACU stay in the postoperative period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroscopy