NCT02181426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 8, 2018

Completed
Last Updated

September 21, 2018

Status Verified

August 1, 2018

Enrollment Period

4.8 years

First QC Date

June 26, 2014

Results QC Date

January 29, 2018

Last Update Submit

September 20, 2018

Conditions

Meniscectomy

Keywords

Knee Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (4)

0 mg of Ketorolac

PLACEBO COMPARATOR

participant receives 0 mg of Ketorolac

Drug: Ketorolac Dose

7.5 mg of Ketorolac

ACTIVE COMPARATOR

participant receives 7.5 mg of Ketorolac

Drug: Ketorolac Dose

15 mg Ketorolac

ACTIVE COMPARATOR

participant receives 15 mg of Ketorolac

Drug: Ketorolac Dose

30 mg Ketorolac

ACTIVE COMPARATOR

participant receives 30mg of Ketorolac

Drug: Ketorolac Dose

Interventions

Ketorolac DoseDRUG

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).

Also known as: Toradol
0 mg of Ketorolac15 mg Ketorolac30 mg Ketorolac7.5 mg of Ketorolac

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to consent and desire to participate in study
  • Outpatient knee arthroscopy with Dr. C. David Geier
  • ASA physical status I-III
  • years old
  • Over 50 kg (110 pounds)
  • General anesthesia

You may not qualify if:

  • 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)
  • Allergy to propofol, fentanyl or hydromorphone.
  • Any chronic painful conditions requiring opioid use for over the last 6 months
  • Emergency surgery
  • Altered mental status (not oriented to place, person or time)
  • Pregnant or lactating patients
  • Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
  • Non-English speaking
  • Patient refusal to study
  • Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29461, United States

Location

MeSH Terms

Interventions

Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Research Coordinator for Anesthesia and Perioperative Medicine
Organization
Medical University of South Carolina, Department of Anesthesia and Perioperative Medicine
joneswr@musc.edu
843-792-2322

Study Officials

  • Sylvia H Wilson, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 4, 2014

Study Start

March 1, 2012

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

September 21, 2018

Results First Posted

June 8, 2018

Record last verified: 2018-08

Locations

US(1)