Oral Ketorolac for Arthroscopic Rotator Cuff Repair

Postoperative Pain Clinical Trial

Official title:

Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967847
• Other study ID #: 20180949
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2019
• Est. completion date: May 17, 2021

Study information

• Verified date: April 2022
• 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 arthroscopic rotator cuff repair.

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 arthroscopic rotator cuff repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 17, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria

1. Patients between the ages of 18 and 89 years old, male or female

2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

1. Patients below the age of 18 or above the age of 89

2. Illiterate or non-English speaking patients

3. Patients with contraindications to Ketorolac

4. History of alcohol of drug abuse

5. Chronic use of analgesic or psychotropic drugs

6. Known peptic ulcer disease or bleeding diathesis

7. Renal dysfunction

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Ketorolac
Oral Ketorolac

Locations

Country	Name	City	State
United States	University Hospitals 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 Analog Scale Scores	The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.	participants were assessed at one single time point up to 8 weeks.
Secondary	Number of Participants With Retear of Rotator Cuff Repair	Assessing retear of rotator cuff repair on postop MRI.	6 months