Dose Response of Ketorolac in Knee Arthroscopy

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

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.

Study Overview

• Status: Completed
• Conditions: Meniscectomy
• Intervention / Treatment: Drug: Ketorolac Dose

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29461
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0 mg of Ketorolac; participant receives 0 mg of Ketorolac	Drug: 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).; Other Names: Toradol
Active Comparator: 7.5 mg of Ketorolac; participant receives 7.5 mg of Ketorolac	Drug: 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).; Other Names: Toradol
Active Comparator: 15 mg Ketorolac; participant receives 15 mg of Ketorolac	Drug: 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).; Other Names: Toradol
Active Comparator: 30 mg Ketorolac; participant receives 30mg of Ketorolac	Drug: 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).; Other Names: Toradol

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Sylvia H Wilson, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Knee Arthroscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: Ketorolac Knee Arthroscopy