- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111381
Toradol to Reduce Ureteroscopic Symptoms Trial (TRUST)
Study Overview
Status
Intervention / Treatment
Detailed Description
This is an investigator-initiated, single-center, prospective randomized clinical trial evaluating the efficacy of intraoperative Ketorolac on post-operative pain in patients undergoing ureteroscopy at Yale-New Haven Hospital.
The study population will include anyone between the age of 18-80 who is undergoing elective ureteroscopy for management of stone disease without contraindication to ketorolac.
Patients who are being consented to undergo a ureteroscopy with the PI will be asked to participate in this study. There is currently no consensus on standard of care regarding intraoperative analgesia for ureteroscopy. There is wide variability in practice, some clinicians choose to administer intraoperative analgesia while others rely only on the sedation effects of general anesthesia. This study is being carried out to see if administration of Ketorolac during ureteroscopy provides a post-operative benefit in pain scores when compared to no treatment.
The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because participants will be under general anesthesia, participants will not know if they received the medication. Following the procedure, the intervention group may continue to use Ketorolac as needed to manage pain. The only difference between the intervention group and the non-intervention group is the one time dose of intraoperative ketorolac.
The FDA approves Ketorolac as a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.
Following assessment of eligibility and documentation of consent to participate in the study, participants will be randomized to receive intraoperative Ketorolac Tromethamine (Toradol®) or not. In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac. Pain will be managed in the standard way with post-operative Ketorolac as needed. In the treatment group, participants will receive one dose of Ketorolac IV 30mg during the procedure. Randomization will occur by the attending anesthesiologist.
For this trial, the investigators, surgical team, and patients will be blinded to the administration of the agent, which is given as an IV Push of 30mg. For patients who are older than 65 years or weight less than 50kg, the dose will be adjusted to 15mg to minimize the risk of bleeding. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of ketorolac may alter their usage of other intra-operative agents and post-operative agents. The surgical team will be un-blinded post-operatively.
Following the procedure, participants will rate their pain using a visual pain assessment scale at 1 hour postoperatively and at the time of discharge from the recovery room. Once the patient is at home, the participant will fill out a validated survey that has questions related to pain. This will be filled out once a day for a total of 7 days following the procedure. In addition, the investigators will provide a medication utilization diary sheet for the participant to record daily use of prescribed narcotic and other as needed over the counter medications such as acetaminophen and ibuprofen.This will also be done daily for a total of 7 days. The participant will be surveyed at a one-week postoperative visit using the same assessment. All adverse drug reactions will be recorded from the time of administration to initial follow-up.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale Medial Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing Ureteroscopy for kidney stone management between age 18-80.
Exclusion Criteria:
- Unable to provide consent
- Contraindications to Toradol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia.
Because the participants will be under general anesthesia, they will not know if they received the medication.
The surgeon will also be blinded to this.
The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents
|
IV toradol
|
No Intervention: Non-Intervention Group
In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Pain
Time Frame: up to 1 week
|
Once the patient is at home, they will fill out a validated visual analog pain scale to rate their pain. This will be filled out once a day for a total of 7 days following the procedure. This is total morphine equivalent use. The range is 0 to infinity. Higher scores are equated to worse pain. The units are "ME" or morphine equivalents. |
up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Complications
Time Frame: 6 weeks post operative
|
6 weeks post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Calculi
- Nephrolithiasis
- Pain, Postoperative
- Kidney Diseases
- Urinary Calculi
- Urolithiasis
- Kidney Calculi
- Lithiasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac Tromethamine
Other Study ID Numbers
- 2000020245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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