Dose Response of Ketorolac in Knee Arthroscopy

Not Applicable

Completed

• Conditions: Meniscectomy
• Interventions: Drug: Ketorolac Dose

• Registration Number: NCT02181426
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-04
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Results First Submitted: 2018-01-29
• Results First Submitted QC: 2018-05-08
• Results First Posted: 2018-06-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0 mg of Ketorolac	Ketorolac Dose	participant receives 0 mg of Ketorolac
30 mg Ketorolac	Ketorolac Dose	participant receives 30mg of Ketorolac
7.5 mg of Ketorolac	Ketorolac Dose	participant receives 7.5 mg of Ketorolac
15 mg Ketorolac	Ketorolac Dose	participant receives 15 mg of Ketorolac

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States