Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.
NCT ID: NCT01230463
Last Updated: 2010-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2010-09-30
2011-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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15 mg ketorolac IV
Ketorolac Tromethamine
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
30 mg ketorolac IV
Ketorolac Tromethamine
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Interventions
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Ketorolac Tromethamine
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Ketorolac Tromethamine
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult 18 - 65 years
* Weight of 50 - 110 kg
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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University of Calgary Department of Anesthesia
Principal Investigators
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Kaylene Duttchen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary - Department of Anesthesia
Melinda Davis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary - Department of Anesthesia
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Central Contacts
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Other Identifiers
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23237
Identifier Type: -
Identifier Source: org_study_id