Pain Clinical Trial
Official title:
Intraoperative Ketorolac Dose of 15 mg Versus the Standard 30 mg on Early Postoperative Pain After Spine Surgery: A Randomised, Blinded, Non-Inferiority Trial
The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery.
Opioids have traditionally been the cornerstone of acute postoperative pain management.
Problematic side effects such as nausea, vomiting, ileus, urinary retention, excess
sedation, and respiratory depression are significant disadvantages with the use of opioids.
Alternative treatments have been sought. The concept of adding a nonsedating non opioid
analgesic agent is appealing and has been validated by previous studies. Nonsteroidal
anti-inflammatory drugs (NSAID) are nonsedating and combine analgesic and anti-inflammatory
properties ideal for pain after surgery.
Ketorolac is a potent intravenous nonsteroidal anti-inflammatory drug (NSAID), and a non
selective cyclooxygenase inhibitor which mediates pain, inflammation and fever. It has been
evaluated and used for treatment of moderate to severe pain including postoperative pain.
Although intravenous route is not approved by Health Canada, its use is supported in medical
literature and clinical practice.
Previous studies have demonstrated the effectiveness of standard 30 mg intravenous ketorolac
as an adjunct to opioids for postoperative pain relief. Standard parenteral dose recommended
by manufacturer for healthy non elderly population is 30 mg based on a number clinical
trials.
Alberta Health Services (AHS) Pharmacy formulary has approved the intravenous use of
ketorolac in the dosage range of 10-30 mg depending the patient's weight and medical
comorbidities.
NSAIDs, including ketorolac, have an analgesic ceiling effect in which higher doses do not
provide any additional pain relief but may increase the likelihood of side effects. Single
dose IM ketorolac have been studied in the past showing no difference in analgesia with the
30 and 90 mg dose. Because of risk of drug toxicity and unwanted side effects, patients
should be given the lowest effective ketorolac dose. Low dose ketorolac was studied in the
adolescents undergoing spine surgery and showed that dose of 0.2mg/kg (11mg) provides
supplemental analgesia postoperatively. However, there were no previous studies found on
review of the literature using medline search that look at parallel comparison between
intraoperative doses of ketorolac in terms of efficacy and safety profile.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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