Clinical trial NCT02181426: Dose Response of Ketorolac in Knee Arthroscopy
Official title: Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscectomy
Keywords: Knee Arthroscopy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: PACU Opiate Consumption
timeFrame: Less than 1 day (PACU stay in the postoperative period)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sylvia H Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: