MedDataX Logo

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

NCT ID: NCT04246554

Last Updated: 2021-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-21

Study Completion Date

2021-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. 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.
2. 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ACL Injury Postoperative Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ACL reconstruction Ketorolac Pain Narcotic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type EXPERIMENTAL

Oxycodone-Acetaminophen

Intervention Type DRUG

Oral oxycodone-acetaminophen for post-operative pain control

Ketorolac

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

Oral ketorolac for pain control following ACL reconstruction surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac

Oral ketorolac for pain control following ACL reconstruction surgery

Intervention Type DRUG

Oxycodone-Acetaminophen

Oral oxycodone-acetaminophen for post-operative pain control

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Karns, MD.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Karns, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cleveland Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UH Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Mengers SR, Strony JT, Sivasundaram L, Yu J, Goodfellow D, Salata MJ, Voos JE, Karns MR. Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study. J Am Acad Orthop Surg. 2022 Dec 15;30(24):e1580-e1590. doi: 10.5435/JAAOS-D-21-00721.

Reference Type DERIVED
PMID: 36476466 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY20180985

Identifier Type: -

Identifier Source: org_study_id