ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 415 for:    KETOROLAC

Dose Response of Ketorolac in Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02181426
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Meniscectomy Drug: Ketorolac Dose Not Applicable

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  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy
Study Start Date : March 2012
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

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 Name: 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 Name: 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 Name: 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 Name: Toradol




Primary Outcome Measures :
  1. PACU Opiate Consumption [ Time Frame: Less than 1 day (PACU stay in the postoperative period) ]
    Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181426


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29461
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Sylvia H Wilson, MD Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02181426     History of Changes
Other Study ID Numbers: Ketorolac Knee Arthroscopy
First Posted: July 4, 2014    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018
Last Verified: May 2018

Keywords provided by Medical University of South Carolina:
Knee Arthroscopy

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action