Toradol to Reduce Ureteroscopic Symptoms Trial (TRUST)
Primary Purpose
Urinary Lithiasis, Kidney Diseases, Kidney Stone
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Toradol
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Lithiasis
Eligibility Criteria
Inclusion Criteria:
- Undergoing Ureteroscopy for kidney stone management between age 18-80.
Exclusion Criteria:
- Unable to provide consent
- Contraindications to Toradol
Sites / Locations
- Yale Medial Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Non-Intervention Group
Arm Description
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
In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
Outcomes
Primary Outcome Measures
Post-operative Pain
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.
Secondary Outcome Measures
Number of Participants With Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03111381
Brief Title
Toradol to Reduce Ureteroscopic Symptoms Trial
Acronym
TRUST
Official Title
Toradol to Reduce Ureteroscopic Symptoms Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Double blinded randomized controlled clinical trial to assess the impact of intraoperative Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone management.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Lithiasis, Kidney Diseases, Kidney Stone, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-Intervention Group
Arm Type
No Intervention
Arm Description
In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
Intervention Type
Drug
Intervention Name(s)
Toradol
Intervention Description
IV toradol
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
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.
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Number of Participants With Complications
Time Frame
6 weeks post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing Ureteroscopy for kidney stone management between age 18-80.
Exclusion Criteria:
Unable to provide consent
Contraindications to Toradol
Facility Information:
Facility Name
Yale Medial Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Toradol to Reduce Ureteroscopic Symptoms Trial
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