Toradol to Reduce Ureteroscopic Symptoms Trial

NCT03111381 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2000020245
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Lithiasis; Kidney Diseases; Kidney Stone; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 1 week

Secondary Outcomes (1)

• Number of Participants With Complications

  6 weeks post operative

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Non-Intervention Group

NO INTERVENTION

In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.

Interventions

Toradol DRUG

IV toradol

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to provide consent
• Contraindications to Toradol

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Medial Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Diseases; Kidney Calculi; Pain, Postoperative

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jamil Syed
• Organization: Yale Urology

Jamil.syed@yale.edu

2037852815

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-08

Locations

US (1)