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Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

Primary Purpose

ACL Injury, Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Ketorolac

Oxycodone-Acetaminophen

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring ACL reconstruction, Ketorolac, Pain, Narcotic

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients between 18 and 89 years old
Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

Patients below age 18 or above age 89
Illiterate or non-English speaking individuals
Patients with contraindications to Ketorolac
History of chronic alcohol or drug abuse
Chronic use of psychotropic or analgesic drugs
Known peptic ulcer disease or bleeding diasthesis
Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
Breastfeeding women
Pregnant women

Sites / Locations

UH Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control

Ketorolac

Arm Description

Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery

Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control

Outcomes

Primary Outcome Measures

Postoperative Visual Analogue Scale Scores

Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.

Secondary Outcome Measures

Narcotic Medication

Number of oxycodone-acetaminophen tablets

Full Information

NCT ID

NCT04246554

First Posted

January 24, 2020

Last Updated

November 24, 2021

Sponsor

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04246554

Brief Title

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

Official Title

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 21, 2019 (Actual)

Primary Completion Date

October 9, 2020 (Actual)

Study Completion Date

January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ACL Injury, Postoperative Pain

Keywords

ACL reconstruction, Ketorolac, Pain, Narcotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Experimental

Arm Description

Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery

Arm Title

Ketorolac

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ketorolac

Intervention Description

Oral ketorolac for pain control following ACL reconstruction surgery

Intervention Type

Drug

Intervention Name(s)

Oxycodone-Acetaminophen

Intervention Description

Oral oxycodone-acetaminophen for post-operative pain control

Primary Outcome Measure Information:

Title

Postoperative Visual Analogue Scale Scores

Description

Time Frame

Up to 8 weeks postoperative

Secondary Outcome Measure Information:

Title

Narcotic Medication

Description

Number of oxycodone-acetaminophen tablets

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients between 18 and 89 years old Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery Exclusion Criteria: Patients below age 18 or above age 89 Illiterate or non-English speaking individuals Patients with contraindications to Ketorolac History of chronic alcohol or drug abuse Chronic use of psychotropic or analgesic drugs Known peptic ulcer disease or bleeding diasthesis Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2) Breastfeeding women Pregnant women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Karns, MD

Organizational Affiliation

University Hospital Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

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