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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246554
• Other study ID #: STUDY20180985
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2021
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 1, 2021
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketorolac
Oral ketorolac for pain control following ACL reconstruction surgery
• Oxycodone-Acetaminophen
Oral oxycodone-acetaminophen for post-operative pain control

Locations

Country	Name	City	State
United States	UH Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Narcotic Medication	Number of oxycodone-acetaminophen tablets	5 days