PainNCT01230463
Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.
A study testing Ketorolac Tromethamine in people with Pain and Pain, Postoperative, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Pain, Postoperative
- What is being tested?
- Ketorolac Tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients booked for 1-2 level spine laminectomies and/or decompression
- Adult 18 - 65 years
- Weight of 50 - 110 kg
Who cannot join
- 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
Show all 9Show fewer
- History of gastrointestinal bleeding
- Pregnancy, history of bronchial asthma
- NSAID use 2 days before surgery.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
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.
Read the 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.
- Conditions
- Pain, Pain, Postoperative
- Being tested
- Ketorolac Tromethamine
- Keywords
- Pain, Postoperative, Ketorolac, Anti-Inflammatory Agents, Non-Steroidal, Intraoperative Care
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called Toradol
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Ketorolac TromethamineDrug
Also called Toradol
30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg ketorolac IV | Active comparator | Not described Receives: Drug: Ketorolac Tromethamine |
| 30 mg ketorolac IV | Active comparator | Not described Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
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.
Measured: Four hours after surgery
Secondary outcomes (3)
Morphine Usage After Surgery
A 10 mg decrease in morphine use in 24 hours is considered clinically significant.
Measured: 8 hours and 24 hours after surgery
Morphine Adverse Effects
Presence of morphine-related adverse effects such as sedation, nausea, vomiting, respiratory depression, and pruritus.
Measured: First 24 hours
Postoperative Bleeding
Hemoglobin levels will be measured before surgery and 24 hours surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Kaylene Duttchen, MD, Principal investigator, University of Calgary - Department of AnesthesiaMelinda Davis, MD, Principal investigator, University of Calgary - Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230463
- Sponsor's protocol ID
- 23237
- Status last verified
- Oct 2010
- First submitted
- 27 Oct 2010
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01230463
- Acronym / sponsor ID
- 23237
- Conditions
- Pain, Pain, Postoperative
- Keywords
- Pain, Postoperative, Ketorolac, Anti-Inflammatory Agents, Non-Steroidal, Intraoperative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 mg ketorolac IV | Active comparator | Drug: Ketorolac Tromethamine |
| 30 mg ketorolac IV | Active comparator | Drug: Ketorolac Tromethamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients booked for 1-2 level spine laminectomies and/or decompression
- Adult 18 - 65 years
- Weight of 50 - 110 kg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineAlso: Toradol15 mg ketorolac IV as a bolus 30 minutes before closure of surgery. | Drug | 15 mg ketorolac IV |
| Ketorolac TromethamineAlso: Toradol30 mg ketorolac IV as a bolus 30 minutes before closure of surgery. | Drug | 30 mg ketorolac IV |
Primary outcome
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.
3 secondary outcomes
Morphine Usage After Surgery
Time frame: 8 hours and 24 hours after surgery
Morphine Adverse Effects
Time frame: First 24 hours
Postoperative Bleeding
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaylene Duttchen, MD principal investigator
University of Calgary - Department of Anesthesia
Melinda Davis, MD principal investigator
University of Calgary - Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac Tromethamine in people with Pain and Pain, Postoperative, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Deguzman, MD (403-944-1991, Cecilia.DeGuzman@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score (time frame: Four hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.