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

October 27, 2010 updated by: University of Calgary

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Toradol
Drug: Ketorolac Tromethamine
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Names:
  • Toradol
Active Comparator: 30 mg ketorolac IV
Drug: Ketorolac Tromethamine
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Names:
  • Toradol
Drug: Ketorolac Tromethamine
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 hours and 24 hours after surgery
Morphine Adverse Effects
Time Frame: First 24 hours
Presence of morphine-related adverse effects such as sedation, nausea, vomiting, respiratory depression, and pruritus.
First 24 hours
Postoperative Bleeding
Time Frame: 24 hours after surgery
Hemoglobin levels will be measured before surgery and 24 hours surgery.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Kaylene Duttchen, MD, University of Calgary - Department of Anesthesia
  • Principal Investigator: Melinda Davis, MD, University of Calgary - Department of Anesthesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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