Dose Response of Ketorolac in Knee Arthroscopy

NCT ID: NCT02181426

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-12-15

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.

Conditions

Meniscectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0 mg of Ketorolac

participant receives 0 mg of Ketorolac

Group Type: PLACEBO_COMPARATOR

Ketorolac Dose

Intervention Type: DRUG

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).

7.5 mg of Ketorolac

participant receives 7.5 mg of Ketorolac

Group Type: ACTIVE_COMPARATOR

Ketorolac Dose

Intervention Type: DRUG

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).

15 mg Ketorolac

participant receives 15 mg of Ketorolac

Group Type: ACTIVE_COMPARATOR

Ketorolac Dose

Intervention Type: DRUG

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).

30 mg Ketorolac

participant receives 30mg of Ketorolac

Group Type: ACTIVE_COMPARATOR

Ketorolac Dose

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Toradol

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia H Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Ketorolac Knee Arthroscopy

Identifier Type: -

Identifier Source: org_study_id