CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
Ketorolac +2 moredrug
Likely dose
Ketorolac 30 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02700451
NCT02700451N/ACompleted

A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes

Hospital for Special Surgery, New York·interventional·Posted Mar 7, 2016·Updated Jul 10, 2023

In Brief

A clinical study evaluating Ketorolac, Acetaminophen, and 1 other intervention for Lumbar Osteoarthritis and 3 related conditions. Completed, enrolled 178 participants across 1 site.

Detailed Summary

Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects. The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \[quicker ambulation with physical therapy (PT), earlier return to work, etc.\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 7, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 31, 2021
Study CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 10.3 years ago

Interventions

Ketorolacdrug

Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Acetaminophendrug

Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Placebodrug

Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.