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Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.

Intraoperative Ketorolac Dose of 15 mg Versus the Standard 30 mg on Early Postoperative Pain After Spine Surgery: A Randomised, Blinded, Non-Inferiority Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01230463
Enrollment
50
Registered
2010-10-29
Start date
2010-09-30
Completion date
2011-09-30
Last updated
2010-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Pain, Postoperative

Keywords

Pain, Postoperative, Ketorolac, Anti-Inflammatory Agents, Non-Steroidal, Intraoperative Care

Brief summary

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.

Detailed description

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.

Interventions

DRUGKetorolac Tromethamine

15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients booked for 1-2 level spine laminectomies and/or decompression * Adult 18 - 65 years * Weight of 50 - 110 kg

Exclusion criteria

* Previous lumbar laminectomy * Current anticoagulant use with INR \> 1.2 * Narcotic use \> 4 weeks * Known allergy or sensitivity to NSAID or morphine * Renal insufficiency with creatinine \>100 umol/L * Known liver disease * History of gastrointestinal bleeding * Pregnancy, history of bronchial asthma * NSAID use 2 days before surgery.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog ScoreFour hours after surgeryTo 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. Minimum clinically significant decrease in VAS pain score is 18 mm.

Secondary

MeasureTime frameDescription
Morphine Usage After Surgery8 hours and 24 hours after surgeryA 10 mg decrease in morphine use in 24 hours is considered clinically significant.
Morphine Adverse EffectsFirst 24 hoursPresence of morphine-related adverse effects such as sedation, nausea, vomiting, respiratory depression, and pruritus.
Postoperative Bleeding24 hours after surgeryHemoglobin levels will be measured before surgery and 24 hours surgery.

Countries

Canada

Contacts

Primary ContactCecilia Deguzman, MD
Cecilia.DeGuzman@albertahealthservices.ca403-944-1991
Backup ContactKevin Yee, MD
kevin.yee@albertahealthservices.ca403-944-1991

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026