Dose Response of Ketorolac in Knee Arthroscopy

Meniscectomy Clinical Trial

Official title:

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181426
• Other study ID #: Ketorolac Knee Arthroscopy
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 15, 2016

Study information

• Verified date: August 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Meniscectomy

Intervention

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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)