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OpenTrials
Completed

NCT Number: NCT04246554

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

Oral ketorolac for pain control following ACL reconstruction surgery

Oxycodone-Acetaminophen

Drug

Oral oxycodone-acetaminophen for post-operative pain control

Primary outcomes

  1. Postoperative Visual Analogue Scale Scores

    Time frame: Up to 8 weeks postoperative

    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 outcomes

  1. Narcotic Medication

    Time frame: 5 days

    Number of oxycodone-acetaminophen tablets

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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