MeniscectomyNCT02181426
Dose Response of Ketorolac in Knee Arthroscopy
A study testing Ketorolac Dose in people with Meniscectomy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscectomy
- What is being tested?
- Ketorolac Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to consent and desire to participate in study
- Outpatient knee arthroscopy with Dr. C. David Geier
- ASA physical status I-III
- 18-65 years old
- Over 50 kg (110 pounds)
- General anesthesia
Who cannot join
- Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
- Allergy to propofol, fentanyl or hydromorphone.
- Any chronic painful conditions requiring opioid use for over the last 6 months
- Emergency surgery
- Altered mental status (not oriented to place, person or time)
- Pregnant or lactating patients
Show all 10Show fewer
- Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
- Non-English speaking
- Patient refusal to study
- Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29461
About this study
Official title: Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy
Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.
Read the detailed description
Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.
- Conditions
- Meniscectomy
- Being tested
- Ketorolac Dose
- Keywords
- Knee Arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac DoseDrug
Also called Toradol
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
| Study group | Role | What they receive |
|---|---|---|
| 0 mg of Ketorolac | Placebo comparator | participant receives 0 mg of Ketorolac Receives: Drug: Ketorolac Dose |
| 7.5 mg of Ketorolac | Active comparator | participant receives 7.5 mg of Ketorolac Receives: Drug: Ketorolac Dose |
| 15 mg Ketorolac | Active comparator | participant receives 15 mg of Ketorolac Receives: Drug: Ketorolac Dose |
| 30 mg Ketorolac | Active comparator | participant receives 30mg of Ketorolac Receives: Drug: Ketorolac Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Opiate Consumption
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Measured: Less than 1 day (PACU stay in the postoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startMar 2012
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MeniscectomyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia H Wilson, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181426
- Sponsor's protocol ID
- Ketorolac Knee Arthroscopy
- Status last verified
- Aug 2018
- First submitted
- 26 Jun 2014
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT02181426
- Acronym / sponsor ID
- Ketorolac Knee Arthroscopy
- Conditions
- Meniscectomy
- Keywords
- Knee Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.
Detailed description
Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mg of Ketorolac | Placebo comparator | Drug: Ketorolac Doseparticipant receives 0 mg of Ketorolac |
| 7.5 mg of Ketorolac | Active comparator | Drug: Ketorolac Doseparticipant receives 7.5 mg of Ketorolac |
| 15 mg Ketorolac | Active comparator | Drug: Ketorolac Doseparticipant receives 15 mg of Ketorolac |
| 30 mg Ketorolac | Active comparator | Drug: Ketorolac Doseparticipant receives 30mg of Ketorolac |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to consent and desire to participate in study
- Outpatient knee arthroscopy with Dr. C. David Geier
- ASA physical status I-III
- 18-65 years old
- Over 50 kg (110 pounds)
Key exclusion criteria (10 listed)
- Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
- Allergy to propofol, fentanyl or hydromorphone.
- Any chronic painful conditions requiring opioid use for over the last 6 months
- Emergency surgery
- Altered mental status (not oriented to place, person or time)
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 DoseAlso: ToradolSubjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | Drug | 0 mg of Ketorolac, 15 mg Ketorolac, 30 mg Ketorolac, 7.5 mg of Ketorolac |
Primary outcome
PACU Opiate Consumption
Time frame: Less than 1 day (PACU stay in the postoperative period)
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sylvia H Wilson, MD principal investigator
Medical University of South Carolina
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 Dose in people with Meniscectomy, run by Medical University of South Carolina at 1 site in United States.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 21 Sep 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PACU Opiate Consumption (time frame: Less than 1 day (PACU stay in the postoperative period)). 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 21 Sep 2018.