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

NCT04246554 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STUDY20180985
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

ACL Injury; Postoperative Pain

Keywords

ACL reconstruction; Ketorolac; Pain; Narcotic

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks postoperative

Secondary Outcomes (1)

• Narcotic Medication

  5 days

Study Arms (2)

Control

EXPERIMENTAL

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

Drug: Oxycodone-Acetaminophen

Ketorolac

EXPERIMENTAL

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

Drug: Ketorolac

Interventions

Ketorolac DRUG

Oral ketorolac for pain control following ACL reconstruction surgery

Ketorolac

Oxycodone-Acetaminophen DRUG

Oral oxycodone-acetaminophen for post-operative pain control

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 36476466 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain, Postoperative; Pain

Interventions

Ketorolac; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This is a single-institution study involving only five surgeons, so patient demographics and outcomes may not reflect a broader population. Neither surgeons nor patients were blinded with regards to medication use. Therefore, subjective pain scores may have been influenced by perceptions of greater pain control in patients who received ketorolac in addition to oxycodone-acetaminophen. The study may be underpowered with regards to functional outcome scores and medication side effects profiles.

Results Point of Contact

• Title: Dr. Michael Karns
• Organization: UH Cleveland Medical Center

srmengers@gmail.com

216-844-7200

Study Officials

• Michael Karns, MD

  University Hospital Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 29, 2020
• Study Start: May 21, 2019
• Primary Completion: October 9, 2020
• Study Completion: January 1, 2021
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Locations

US (1)