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Toradol to Reduce Ureteroscopic Symptoms Trial (TRUST)

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ClinicalTrials.gov Identifier: NCT03111381
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Urinary Lithiasis Kidney Diseases Kidney Stone Pain, Postoperative Drug: Toradol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Toradol to Reduce Ureteroscopic Symptoms Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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
Drug: Toradol
IV toradol

No Intervention: Non-Intervention Group
In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Narcotic/analgesia usage [ Time Frame: up to 1 week ]
    In addition, the investigator will provide a medication utilization diary sheet for the patient 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 their one-week postoperative visit using the same assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide consent
  • Contraindications to Toradol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111381


Contacts
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Contact: Piruz Motamedinia, MD piruz.motamedinia@yale.edu
Contact: Jamil Syed, MD 203-928-7036 Jamil.syed@yale.edu

Locations
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United States, Connecticut
Yale Medial Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Piruz Motamedinia, MD         
Sponsors and Collaborators
Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03111381    
Other Study ID Numbers: 2000020245
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Calculi
Urolithiasis
Pain, Postoperative
Lithiasis
Urologic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nephrolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action