Toradol to Reduce Ureteroscopic Symptoms Trial (TRUST)

November 1, 2021 updated by: Yale University
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

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

    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Medial Center

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing Ureteroscopy for kidney stone management between age 18-80.

Exclusion Criteria:

  • Unable to provide consent
  • Contraindications to Toradol

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: 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

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

Sponsor

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 (Actual)

August 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

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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