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

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain
ACL Injury

Treatments

Drug: Ketorolac
Drug: Oxycodone-Acetaminophen

Study type

Interventional

Funder types

Other

Identifiers

NCT04246554
STUDY20180985

Details and patient eligibility

About

  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.

Enrollment

49 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Control
Experimental group
Description:
Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery
Treatment:
Drug: Oxycodone-Acetaminophen
Ketorolac
Experimental group
Description:
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
Treatment:
Drug: Ketorolac

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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