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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01230463
Recruitment Status : Unknown
Verified October 2010 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : October 29, 2010
Last Update Posted : October 29, 2010
Information provided by:
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Pain Pain, Postoperative Drug: Ketorolac Tromethamine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 15 mg ketorolac IV Drug: Ketorolac Tromethamine
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Name: Toradol

Active Comparator: 30 mg ketorolac IV Drug: Ketorolac Tromethamine
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Name: Toradol

Primary Outcome Measures :
  1. Visual Analog Score [ Time Frame: Four hours after surgery ]
    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. Minimum clinically significant decrease in VAS pain score is 18 mm.

Secondary Outcome Measures :
  1. Morphine Usage After Surgery [ Time Frame: 8 hours and 24 hours after surgery ]
    A 10 mg decrease in morphine use in 24 hours is considered clinically significant.

  2. Morphine Adverse Effects [ Time Frame: First 24 hours ]
    Presence of morphine-related adverse effects such as sedation, nausea, vomiting, respiratory depression, and pruritus.

  3. Postoperative Bleeding [ Time Frame: 24 hours after surgery ]
    Hemoglobin levels will be measured before surgery and 24 hours surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230463

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Contact: Cecilia Deguzman, MD 403-944-1991
Contact: Kevin Yee, MD 403-944-1991

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Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
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Principal Investigator: Kaylene Duttchen, MD University of Calgary - Department of Anesthesia
Principal Investigator: Melinda Davis, MD University of Calgary - Department of Anesthesia

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Responsible Party: Kaylene Duttchen, University of Calgary Department of Anesthesia Identifier: NCT01230463     History of Changes
Other Study ID Numbers: 23237
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by University of Calgary:
Pain, Postoperative
Anti-Inflammatory Agents, Non-Steroidal
Intraoperative Care
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action