NCT04246554

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

Completed Phase 3 Results posted Last updated 21 December 2021

What this trial tests

Phase 3 trial testing Ketorolac in ACL Injury in 49 participants. Completed in 1 January 2021.

Timeline

21 May 2019

Primary endpoint
9 October 2020

1 January 2021

Quick facts

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	21 May 2019
Primary completion	9 October 2020
Estimated completion	1 January 2021
Sites	1 location across United States

Drugs / interventions tested

• Ketorolac (KETOROLAC) — full drug profile →
• Oxycodone-Acetaminophen

Conditions studied

• ACL Injury — all drugs for ACL Injury →
• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

University Hospitals Cleveland Medical Center

Who can join

Adults 18 to 89, any sex, with ACL Injury or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postoperative Visual Analogue Scale Scores Primary · 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.

Group	Value	95% CI
Control	50.4	± 5.3
Ketorolac	40.0	± 4.9

Narcotic Medication Secondary · 5 days

Number of oxycodone-acetaminophen tablets

Group	Value	95% CI
Control	12.4	± 1.4
Ketorolac	5.5	± 1.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control

Serious: 0/26 (0%)

Deaths: 0/26

Ketorolac

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (9 terms — click to expand)

Reaction	System	Control	Ketorolac
drowsy	Nervous system disorders	—	—
nausea/ vomitin	Gastrointestinal disorders	—	—
dizzy	Nervous system disorders	—	—
constipation	Gastrointestinal disorders	—	—
indigestion	Gastrointestinal disorders	—	—
headache	Nervous system disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
bleeding	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT04246554 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study.
   Mengers SR, Strony JT, Sivasundaram L, Yu J, et al · · 2022 · cited 3× · PMID 36476466 · DOI 10.5435/jaaos-d-21-00721