Dose Response of Ketorolac in Knee Arthroscopy

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Meniscectomy

Treatments: Drug: Ketorolac Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02181426

Ketorolac Knee Arthroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 4 patient groups, including a placebo group

0 mg of Ketorolac

Placebo Comparator group

Description:

participant receives 0 mg of Ketorolac

Treatment:

Drug: Ketorolac Dose

7.5 mg of Ketorolac

Active Comparator group

Description:

participant receives 7.5 mg of Ketorolac

Treatment:

Drug: Ketorolac Dose

15 mg Ketorolac

Active Comparator group

Description:

participant receives 15 mg of Ketorolac

Treatment:

Drug: Ketorolac Dose

30 mg Ketorolac

Active Comparator group

Description:

participant receives 30mg of Ketorolac

Treatment:

Drug: Ketorolac Dose